Xconomy published today on Qiagen's recent application to the FDA for the approval of a diagnostic test that looks at a mutation in the EGF receptor. The test is useful in the diagnosis of the speed of disease spread in non-small cell lung cancers (NSCLC) -- 10 to 15 percent of Caucasions and 40 percent of Asians carry the mutation. The test was developed in conjunction with Boehringer Ingelheim's cancer therapy, afatinib that targets the mutation -- and they've asked the FDA to approve both products simultaneously.
This type of "companion diagnostic" has long been talked about, particularly with cancers, as being advantageous to define the target patient population that will respond to the drug. This helps recruitment for clinical trials and to better ensure the drug will actually be effective in the trial. The proto-type for this concept is Roche's combination Herceptin and the HER2 positive breast cancer from the late 90's. But not much else has really reached the market since then.
With Qiagen's/BI's application, we expect to see a new surge in companion diagnostics-therapeutic combination being developed and brought forth. In fact, co-development of the therapy and the diagnostic is the major difference in these programs now compared to what may have been done in the past where a test was typically developed sometime well after the therapy was available. The result is that the tests didn't work particularly well and only 1% of drugs in the US actually have a companion diagnostic -- most in cancer area.
That's changing as the FDA has encouraged this approach. Qiagen says it now has 15 programs in progress -- including with not only BI -- but with big companies like Pfizer and AZ. Last year, Roche had a companion diagnostic it developed with its Zelboraf treatment for melanoma. Pfizer's Xalkori has a companion diagnostic developed by Abbott. Other drug-companion diagnostic programs in progress include the following companies:
- Synadex Pharmaceuticals and Ventana Medical with entinostat & NSCLC's
- Seattle Genetics/Takeda and Ventana Medical with Adcetris & hopefully various cancers
- Qiagen and Bayer with tests therapies and tests for solid tumors
- Qiagen also has a similar deal with Pfizer
- Astellas Pharma and Roche with Tarceva and lung cancers
The industry and FDA are looking for more of these to be successful -- and would expect clinical trials to flow more smoothly and result in more approved drug applications. It remains to be seen if this will translate into reality -- though the promise is clearly there.
Posted by Bruce Lehr Jan 31st 2013.