The Big Red Biotech Blog

First mAb Submitted to EMA for Biosimilar Approval

A biosimilar version of Remicade (anti-TNF drug) is the first mAb to be submitted to the EMA for review.  Celltrion is believed to be the company making the submission, although this has not been formally revealed.  Celltrion has conducted clinical trials with its version of the drug in 19 countries over the past 2 years. There are 16 -- yes 16 -- approved indications for Remicade.  It is not known if Celltrion is seeking approval for only the RA indication (matching trials) or going for additional indications as well.  Extrapolation of safety and efficacy data from one indication to others is allowed potentially so it is a pertinent question.

First Monoclonal Antibody Submitted to EMA for Biosimilar Approval.

 The anti-TNF market is estimated to be worth $21 B. Analysts are torn as to whether a biosimilar version is a bigger threat to J&J's Remicade or whether a (humanized) biobetter version of the antibody will more likely prevail.  J&J has its own humanized replacment called Simponi. Celltrion is betting on gettig share however and is submitting its application well ahead of Remicade's 2014 patent expiration date. Celltrion will also go to Korea and other emerging markets in Asia and Central/South America where Remicade is not under patent.

Now, we all wait to see how Celltrion's application does at EMA.  More mAb biosimilar applications are expected to be submitted to EMA this year.  Whether these have a huge impact on the market, depends upon how easily they are approved and whether companies like Celltrion (or Samsung) can make good on their promise to drop prices by 40-50% over the reference product. The race has begun in earnest now.

Posted by Bruce Lehr May 2nd 2012.

Big News for Vertex and CF Patients

 

The FDA approved Vertex's second drug today when it ratified Kalydeco (ivacaftor) for sale to cystic fibrosis patients with the G551D mutation.  These patients represent about 4% of the US CF population or about 1200 patients.  There are another 1000 such patients in Europe.  Vertex is seeking approval in the EU by Qtr 3 in 2012.

FDA OKs Vertex Drug For Cystic Fibrosis; $294K/Yr // Pharmalot.

Kalydeco represents the first drug that actually corrects for the dysfunctional CF protein CFTR that results in disease for these patients.  Genetic tests will reveal which patients have the G551D mutation and therefore will be good candidates for the drug. In clincal trials, Kalydeco resulted in significant improvement to lung function, reduced side effects and improved quality of life. The drug will cost $294,000 per year per patient.  Analysts predict peak sales of Kalydeco of around $550 M annually. The drug also carries orphan status.

There is real excitement that this targeted therapy made it thorugh the FDA in 3 months -- a record.  This is also the 2nd personalized medicine drug in approved by the FDA over the past few days.  It shows the high-level agency interest in programs of this sort and their favorable disposition.

"Kalydeco is an excellent example of the promise of personalized medicine --- targeted drugs that treat patients with a specific genetic makeup," said FDA Commissioner Margaret Hamburg.

The drug was part of a 13 year development program with the CF Foundation, which spent almost $70 M towards development.  The CFF will now also benefit with this approval by collecting royalties that start in "high single digits" and could reach as high as 12 percent. A first and a win for this type of collaboration.  See Xconomy, Fierce Biotech, and PharmTech Talk.

 

Posted by Bruce Lehr Jan 31st 2012.

Genentech and Curis Gain FDA Approval for Drug to Treat Skin Cancer

Another biological oncology drug received approval from the FDA today.  This time it was Genentech and Curis' drug vismodegib (marketed as Erivedge) for the treatment of basal cell carcinoma, a common skin cancer.  They won the approval well ahead of the agency's decision deadline. And top regulators signaled that they would look kindly on other developers who take the same approach to targeted therapeutics.

The drug will be used to treat BCC patients who's cancers have spread after surgeries or other treatments. The median progression-free survival rate was 9.5 months. Erivedge is the first drug that targets the hedgehog signaling pathway that has been approved.  More are on the way. See Xconomy.

This is Curis' first approved drug. The company is now due a $10 M milestonepayment from Genentech upon the approval. Curis also stands to earn royalties on sales.  Curis investors spared no time in starting to cash in by selling their shares in brisk trading today.

Posted by Bruce Lehr Jan 30th 2012. 

FINALLY! Bydureon Gets Through FDA

The FDA posted its approval of Bydureon to its website today. It's official.  Amylin (and Alkermes) will be able to market its once-weekly injectable GLP-1 diabetes medication.  It will now move into a closely watched competition with Novo's Victoza (also a GLP-1 drug). 

Since the last delay at the FDA in October 2010, Amylin has broken up with its co-marketing partner Eli Lilly and will be on its own in marketing the drug.  Lilly received $250 M to dissolve the partnership and will get $150 M with the FDA approval. It will also receive a 15% royalty on sales until a $1.2 billion note has been satisfied. Analysts say that Amylin sales of Bydureon could reach a peak value of $1.8 billion annually by 2018. See Xconomy, Seeking Alpha and Pharmalot.

If at first you don't succeed, try try again.

Posted by Bruce Lehr Jan 27th 2012.

Do FDA Approvals Even Guarantee Success?

Much has been made about the welcomed increase in the number of FDA approved new drugs in 2011 -- up to 30 this year.  Time for a hip-hip-hurrah no doubt. See Fierce Biotech.

I'm not so sure though if you worked for Dendreon (Provenge) or Human Genome Sciences (Benlysta).  Both companies -- when the afterglow of approval waned -- experienced slower than forecasted sales.  The result was that Dendreon's stock price plummeted more than 60% overnight when its Q3 earnings were released. The Company was forced to layoff more than 500 (mostly manufacturing) employees shortly thereafter. See Pharmalot and Seeking Alpha.

Much the same story has occured with HGS.  It's sales have lagged -- only $25 million in Q4.  It's stock price has suffered.  It is now going to layoff more than 150 of its staff.  So much for the first lupus drug in 50 years showing a quick sales takeoff. See Fierce Biotech.

Analysts and investors still remain cautiously optimistic that both treatments will catch on -- but the jury is out -- and it shows that the FDA is NOT the only obstacle to filling the coffers with geld when it comes to new drug approvals. You still have to pass muster with the subscribers and reimbursement community too.

Posted by Bruce Lehr Jan 10th 2012.

2011 Final FDA Drug Approval Statistics

The FDA approvals for full year 2011 can now be formally tallied.  The agency did approve more drugs this year than it has for any of the past seven.  Some points include 30 new drugs approved, including many novel applications that were approved in the US first.  Both J&J and GSK each achieved 3 new approvals.

Analysts attribute the higher approval numbers to such things as pharma's improved data packages being submitted with drug applications, specifically with more safety data.  Pharma companies also appear to be picking better candidates that represent more novel treatments as drug they preferential push toward approval.

The agency for its part says it is trying to streamline the approval process -- a process that heretofore has been under heavy criticism by pharma company's, industry analysts and investment groups. It remains to be seen if 2012 will be as rosy -- but we can start 2012 optimistically can't we?  See Fierce Biotech.

Posted by Bruce Lehr Jan 6th 2012.

Jury Still Out on FDA Approval Rate

The jury is still out on whether the FDA increased drug approval rate in 2011 represents the start of a more positive trend or is just a one year hiccup. By November the FDA had 35 approvals to claim--with 24 coming ahead of OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates. 

True, but will it be sustained?

Most industry execs aren't ready to cheer just yet. The industry is still struggling with a poor productivity rate over the past decade, and is undergoing an unfinished revolution on the development front.  Next year, we could see a drop in approvals.  And if that happens, the FDA will be under even more pressure to work more closely with developers to better turn the odds in their favor.  See Fierce Biotech.

Posted by Bruce Lehr Dec 26th 2011.

EMA Stats Point To Improved Pipelines

According to PharmTech Talk approvals in EMA in 2011 look much rosier than the picture seen at the end of 2010 -- and this may give us hope that this will continue in 2012 and beyond. Let's look at the numbers.

PharmTech Talk » EMA Stats Point To Improved Pipelines.

2010 Jan - Dec

• positive opinions 51
• finalized marketing authorization applications 54
• finalized new drug applications 21
• finalized new orphan drug applications 6

2011 Jan - Sep

• positive opinions 74
• finalized marketing authorization applications 79
• finalized new drug applications 32
• finalized new orphan drug applications 11

There seems to be a pretty substantial increase in authorizations even when comparing a partial year 2011 to a full [dismal] year in 2010 - which coudl be interpreted as a sign of hope for the industry in 2012.

Posted by Bruce Lehr Nov 11th 2011.

 

 

 

 

 

 

 

FDA Approves 35 Drugs in 2011 YTD

The FDA released a statement touting that it has approved 35 drugs YTD which is only 2 less than its best year in the past 10 years (37 in 2009).  What's more?  The approval times are faster than elsewhere - 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union.

The FDA Approved How Many New Drugs? // Pharmalot.

According to the agency, of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months (you can read the complete report here).

Beat your drum loudly while you can.

 

 

 

 

Posted by Bruce Lehr Nov 3rd 2011.

FDA Panel Recommends Xarelto

There had been speculation earlier this week the J&J and Bayer's new blood thinner Xarelto might run into problems with an FDA advisory panel, when some alleged gaps in its safety data with certain heart patients was raised in a memo by FDA reviewers. 

FDA Panel Recommends The Xarelto Bloodthinner // Pharmalot.

Nevertheless, the FDA advisory panel voted 9-2 to recommend the agency approve the drug.  Xarelto, if/when approved, will be another drug that replaces the old standard warfarin.  It will have competition though from the recently approved Pradaxa from BI and a forthcoming drug from Pfizer and BMS called Eliquis.  Eliquis is supposed to have the best clinical data of the three.

 

 

Posted by Bruce Lehr Sep 8th 2011.

Niche Cancer Drugs Making Inroads

Fierce Biotech reminds us today that new cancer drugs aimed at defined patient niches and paired with a companion diagnostic are starting to see regulatory success in the market.  Yesterday, Pfizer's crizotinib received approval for the treatment of non-small cell lung cancer in ALK+ patients.  It will be marketed under the trade name Xalkori (former consort of Xena Warrior Princess).  It's priced at $115,000 per year and analysts are pegging it to hit $540 million in annual revenues by 2015. 

Similarly, Roche's Zelboraf (vemurafenib) and its companion diagnostic (and $56,000 6-months price tag) were approved earlier this month for the treatment of certain melanoma patients.  It in fact received accelerated approval as the agency appears to be motivated to get these type of targeted therapies on the market. The FDA has now approved 25 drugs so far this year (as compared to 21 all of 2010) and is rolling toward a big year.

With this type of encouragement, Big Pharma can be expected to deliver more targeted therapies (with high prices) to help replace its cadre of expiring broad population blockbusters (e.g. Lipitor) as the drug strategy begins to shift.  I personally hope to see more of these targeted drugs make it to market sooner rather than later.  See Fierce Biotech 1 and Fierce Biotech 2.

Posted by Bruce Lehr Aug 30th 2011.

Roche Gets Early Approval Too for Zelboraf

Earlier this week, Roche also got early approval for its cancer drug Zelboraf (vemurafenib) for the treatment of BRAF V600E melanoma -- a full two months ahead of its PDUFA date. The approval marked a key milestone in personalizing treatment of metastatic melanoma.  This is good news for melanoma patients.  In fact, it is the second major new drug approved against melanomas this year -- the other being BMS' Yervoy (ipilumumab). 

Zelboraf is a small molecule tyrosine kinase inhibitor that targets BRAF --  specifically the V600E mutation.  This mutation is seen in approximately half of patients with metastatic melanoma.  The companion diagnostic (also from Roche) will enable oncologists to test patients upfront and determine who should receive the therapy since the clinical results have only been demonstrated in those with the mutation.  That's cool.  We can identify a clear population in which the drug will work.

As mentioned in the previous post on Adcetris, pricing is a hot topic of interest.  Roche plans to sell the drug for $56,400 per treatment course. Yervoy (mentioned above) sells for approximately $120,000 per course.  Wow these are expensive but do result in progression free survival in range of 5-6 months.  All in all it is an advance in the treatment of melanoma patients.  And it also represents a continuation of the increase in the number of approvals that we are seeing from the FDA. See the Pharma Strategy blog for more.

 

 

Posted by Bruce Lehr Aug 19th 2011.

FDA Clears Seattle Genetics' Adcetris for Sale in US

Cue the Trumpets!  Seattle Genetics gained FDA approval to market its antibody drug conjugate (ADC) brentuximab vedotin for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  Yeah!

This is the first ADC to gain approval on the US market and it will be sold under the name Adcetris.  The approval came about two weeks ahead of the official review date of August 30th.  This is great news for Seattle Genetics as it is the Company's first approved drug after being in business for 14 years and spending nearly $546 M in R&D to reach this point.

The industry has been watching the progress of so-called "empowered antibodies" -- antibodies linked to powerful toxins to target specific cancers -- and a big success here for Seattle Genetics will only embolden other companies in the field. Seattle Genetics also has several more candidates of its own in various stages of the clinical pipeline. 

The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22.  See Xconomy. 

 

Posted by Bruce Lehr Aug 19th 2011.

Bydureon Review Date Set

In the continuing saga that is Bydureon approval (or not) by the FDA, we at least now have a formal date for the next decision.  The three partners in crime Amylin Pharmaceuticals, Alkermes and Eli Lilly said today that the FDA has set a deadline of Jan. 28 to complete its review of the updated application for exenatide once-weekly (Bydureon). The companies are seeking FDA clearance to start marketing the new product as the first once-weekly injectable medicine for diabetes patients in the U.S. The drug was approved in the European Union in June.  See Xconomy.

Once approved - Amylin and Lilly can decide whether they will actually try selling the product together or keep on suing each other over Byetta/linagliptin spat.

Posted by Bruce Lehr Aug 12th 2011

Roche to Receive Early Approval for Melanoma Treatment

Reuters reports that Roche's experimental melanoma drug vemurafenib appears headed for an early approval by the FDA, well ahead of its scheduled November 11 date. The agency is apparently encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy.

Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. Others include Bristol-Myers Squibb's melanoma drug Yervoy and J&J's prostate cancer therapy Zytiga, and Dendreon's Provenge also for prostate cancer.  Peak sales of vemurafenib have been estimated at more than $700 million a year.  See Fierce Biotech.

The Pharma Strategy blog notes that Roche and BMS, the manufacturers of ipilimumab (Yervoy), have now met to discuss and finalize the much anticipated combination trial of Zelboraf and Yervoy.  It will be interesting to see if the combination will extend survival even further in patients with the BRAFV600E mutation.

Yervoy was launched recently with a $120K price tag for four infusions.  Sales are apparently were good in Q2.  It is given as a 3mg infusion every three weeks for 4 cycles, over a 3 month period.  It will be interesting to see what the Zelboraf monthly price will be, assuming it successfully garners approval.   Should the combination work out in the future, the cost of treating metastatic melanoma will likely become even more expensive despite only small incremental survival benefits. 

It will also be interesting to see how this expensive cocktail with relatively modest survival benefits will fare at this high cost - especially vis a vis Dendreon's Provenge.  The latter offers about a 4 months survival benefit at a cost of $93,000 per patient that is incurred in about 1month of treatment.  Dendreon has reported issues in getting physician's to prescribe the cost dense Provenge due to reimbursement concerns.  Will a Yervoy and Zelboraf cocktail surmount this hurdle?  If the cocktail does succeed, is that indicative of a better patient benefit or a better selling strategy to prescribers and third-party payers?

 

Posted by Bruce Lehr Aug 9th 2011.

FDA's Biosimilar Approval Path Looks Complex

Fierce Biotech reports that a leading group of FDA regulators have published in the NEJM the  "agency's thinking" on the proposed pathway to gain approval for a biosimilar.  It looks to be complex and customized to the product in question.  Anyone looking for a short, simple, straightforward and inexpensive abbreviated pathway need not apply.

The regulators say that there will be no "one size fits all" systematic assessment for biosimilars. Instead developers will need to integrate various types of evidence "since it seems possible to exceed a current state-of-the-art analytic characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary methods."  That sentence is a mouthful and certainly implies to me a high level of regulatory rigor.

The FDA warns it will need to create a new "paradigm" for its initial discussions with biosimilar developers, with a more extensive product review to detail the additional data needed for a biosimilar approval. Rules on interchangeability, which would allow doctors to switch a branded biologic for a biosimilar, are still in the works.  

Bottom line, the FDA is setting clinical demands that will raise effort and expenses to meet approval requirements. This will undoubtedly limit the field to larger players who will have the financial wherewithal and reosurces to compete.

 

 

Posted by Bruce Lehr Aug 4th 2011.

 

 

Comments on "improved" NDA Approvals in 2011

The Life Sci VC blog takes a closer look at the improved rate of 2011 approvals of NDAs by the FDA.  A couple weeks ago, many commentators -- and including FDA's Janet Woodcock -- ballyhooed the improvement in NDA approval rates and wondered aloud if this signalled big pharma R&D turning the corner toward more success in development of new drugs -- especially given some changes in R&D models over the past years.

Bruce Booth took a bit more somber (and realistic) approach to the data.  He noted two facts that should be considered before one declares unconditional victory in revamping the big pharma R&D machine.  Firstly, Booth notes that the majority of new NDAs were not sponsored by the originating organization and only 7 of 18 came from big pharma.  Thus, most did not originate the sponsors R&D group but rather in its BD group.  The jury must remain out on the value of any new R&D structures or models that have been implemented in the past five years as this data really doesn't speak to those changes.

Secondly, Booth noted that most of the newly improved drugs have been in development a long long long time -- since the 1990's -- and again appear to be from legacy R&D efforts rather than from any new fangled permutation that has arisen since then.  So again, any new changes in R&D will have to await their day in court to assess whether they are more effective than "the old ways". 

Finally, Booth concludes, it is great to celebrate the increased rate of NDA approvals but it is too early to attribute it to changes in R&D models.  One can also conclude that business development activity is very important in the mix of bringing new drugs to market.  And, one cannot forget that the time to market is a very long and complex journey making it damn difficult to assess the effectiveness of   changes to the R&D model in the short-term.

Posted by Bruce Lehr July 29th 2011.  

And Then There Were Two - Adcetris Gets OK for ALCL

Seattle Genetics' Adcetris (brentuximab vedotin) recieved its second thumbs up from a second FDA advisory panel today -- this time for the treatment of anaplastic large cell lymphoma (ALCL).  Once again, the panel voted 10-0 to recommend the drug's approval. 

About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months. The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new drug will be Seattle Genetics’ first marketed product after 14 years in business, and it would the first commercially successful version of an “empowered antibody” -- a completely new type of molecule in the fight against cancer. See Xconomy.

 

Posted by Bruce Lehr July 14th 2011.

 

 

BMS' Yervoy Gains EU Approval

BMS' Yervoy (ipilimumab) is now approved in Europe to be used in the treatment of advanced melanoma. The drug was approved in March for use in the US and is the first treatment to extend lives of patients with melanoma.  BMS gained the drug when it acquired its partner Medarex and its pipeline. 

Since, Yervoy's approval in March, BMS has worked a collaboration deal with Roche to test Yervoy as a combination therapy.  BMS says it will look to do more of these type of deals in the future as combination therapies are expected to gain in popularity as a treatment strategy. See Fierce Biotech.

 

Posted by Bruce Lehr July 14th 2011.  

 

Seattle Genetics' Adcetris Gains FDA Panel Endorsement

Seattle Genetics, as expected, got the endorsement of an FDA advisory panel to approve Adcetris (brentuximab vedotin) for the treatment of Hodgkin's lymphoma.  If the drug is now approved by the FDA for sale (decision Aug 30th), it will be the first approved antibody drug conjugate (ADC) on the market.  Another FDA expert panel will be discussing this afternoon whether or not Adcetris should also be recommended for the treatment of anaplastic large cell lymphoma (ALCL). 

"Brentuximab works and it works well. People with Hodgkin's lymphoma will have another option for treating a terrible disease," said Michael Sekeres, an oncologist at the Cleveland Clinic. See Xconomy. 

Seattle Genetics will not only be gaining its first approved drug but as an ADC the first one of that class.  This is the second drug this year from the Seattle biotech pool, besides Dendreon's Provenge, that represents a novel treatment type for a cancer.  Fierce Biotech notes in an article today that Dendreon and Seattle Genetics would both appear to be high on Big Pharma's short list of acquisitions.  Cancer therapies are expected to grow twice as fast as the rest of the pharmaceutical market (according to IMS Health) and many novel oncology drugs have been approved so far in 2011 (see next post on Yervoy).  Indeed, look for more acquisitions in the oncology space to happen.

 

Posted by Bruce Lehr July 14th 2011.

 

 

FDA's Woodcock says Drug Approvals at 20-year high

The FDA's Janet Woodcock, Director CDER, testified before Congress that the number of new chemical and molecular entity approvals had reached a 20-year high to date in 2011. Twenty drugs have been approved in 2011 so far as compared to 21 drug for all of 2010.

Woodcock further pointed out that the low number of approvals was more a function of attrition in the pharma pipelines than due to regulatory rulings by the FDA.  A recently issued report states that drugs moving to phase III dropped by 55% in 2010, with comparable decreases of 50% and 47% for phase II and phase I respectively.  Thus, the number of drugs reaching a submission for approval is down and therefore the number of approvals would be expected to follow.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 8th 2011.

J&J's Xarelto Passes FDA Scrutiny

J&J's Xarelto has been approved by the FDA for the treatment of venous thromboembolism (VTE) in a unique oral formulation that is taken once per day. The Company considers it one of its top 6 candidates in the pipeline and analysts believe it is poised to take a healthy share of what could be a $20 billion market.  The current market standard, warfarin, has been in practice for more than 50 years but has safety issues that could be improved upon by the newer competitors coming to market now.

J&J's approval -- though delayed for a couple years in the FDA -- still places it ahead of rival Pfizer's efforts with its own Factor Xa inhibitor, apixaban.  The head starts may be worth millions in the market place.  J&J is also pursuing additional applications for Xarelto -- the next being the prevention of strokes in patients suffering from atrial fibrillation. See Fierce Biotech.

 

 

Posted by Bruce Lehr July 5th 2011.

Cha-Ching! Seattle Genetics Gets $5M Milestone from Takeda for ADC

Seattle Genetics has begun to cash in on its antibody drug conjugate (ADC), brentuximab vedotin, for reaching a key milestone by filing an MAA with the European Medicines Agency (EMA).  The milestone triggers a $5 M payment from its licensing partner The Takeda Oncology Company.

Seattle Genetics retains marketing rights to brentuximab vedotin in the US and Canada while Takeda has the rights in the rest of the world. The partners are splitting development costs 50:50. The drug will be targeted to the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). Seattle Genetics application with the US FDA is pending for both applications as well.

The review date with the FDA is scheduled on Bastille Day (July 14th) and the action date is August 30, 2011. See PBR story.

 

Posted by Bruce Lehr June 28th 2011.

FDA Sets Review Date on SGN-35 ADC

Seattle Genetics has its review date with the FDA set for July 14th to get an Advisory Committee decision on its antibody drug conjugate (ADC) brentuximab vedotin (SGN-35).  BLA's for the drug's use in the treatment of Hodgkin's and anaplastic large cell lymphoma will both be reviewed in back to back sessions.

SGN-35 remains on pace to be the first ADC approved.  And if the committe recommendation is positive as widely expected, Seattle Genetics will be really have something to celebrate (besides Bastille Day) as it moves to storm the market.

 

Posted by Bruce Lehr June 16th 2011.

FDA Bests EMA on Speed to Cancer Drug Approvals

If you feel the need for speed, then you perhaps should pursue your new cancer drug approval through the FDA instead of the EMA to get on the market more quickly says a new study. Friends of Cancer Research in studying 23 new cancer drug submissions filed with both agencies found that ALL 23 made it through the FDA first. The FDA took only half the time too -- 350 days in EMA versus half that at FDA.

FDA Commissioner Margaret Hamburg said that the study "reflects FDA's commitment to foster access to effective therapies in a responsive and timely manner."  See Fierce Biotech.

 

 

Posted by Bruce Lehr June 16th 2011.