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after it turned out the drug did not help patients live longer than older therapies. A few years later AstraZeneca partnered with Qiagen to develop a test that would identify those patients with the specific mutation that the drug targets, and in 2009 the two companies won European approval for both the test and the drug, breathing new life into gefitinib.
The FDA sent a clear signal that it will look kindly on joint cancer drugs/test filings in August 2011, when it approved two such pairings in rapid succession: Roche’s vemurafenib (Zelbarof) for metastatic melanoma along with a test also developed by Roche; and crizotonib (Xalkori), made by New York-based Pfizer (NYSE: [[ticker: PFE]]) for non-small cell lung cancer, with a test by Abbott Laboratories (NYSE: [[Ticker:ABT]]) of Abbott Park, IL. Both the Roche and Pfizer drugs target mutations found only in a very small percentage of patients, and both companies said at the time that the parallel development of a companion diagnostic enabled them to speed up the timeline for their drugs.
Since then, deals between test makers and oncology drug companies have only accelerated.
• Syndax Pharmaceuticals of Waltham, MA, teamed up with Ventana Medical Systems, a Roche subsidiary, in January 2012 to develop a test to identify lung cancer patients most likely to respond to its experimental drug entinostat, for non-small cell lung cancer.
• In April 2012 Seattle Genetics (NASDAQ: SGEN), based in Bothell, WA, and Millennium announced a partnership withVentana to develop a companion diagnostic for brentuximab vedotin (Adcetris), a non-Hodgkins lymphoma drug approved in August 2011. Their goal is to be able to identify not only non-Hodgkins patients most likely to respond to the drug, but to identify other cancers with the same mutations.
• In October Qiagen inked a deal with Germany’s Bayer to develop diagnostics in conjunction with targeted therapies for solid tumors, starting at the very earliest stage of drug discovery. Qiagen already had a similar deal in place with Pfizer.
• This month Japan’s Astellas Pharma and Roche filed with the FDA for joint approval for an expanded use of Astellas’ erlotinib (Tarceva) in lung cancer using Roche’s companion diagnostic.
The dual development approach doesn’t always work, however. In September, MolecularMD of Portland, OR, pulled its FDA application for a companion diagnostic for Cambridge-based Ariad Pharmaceutical’s ponatinib, then also under review for treatment of two rare types of leukemia. The FDA had informed MolecularMD that its test didn’t qualify as a companion diagnostic because it didn’t “provide information that is essential for the safe and effective use” of the drug. The withdrawal didn’t harm the application from Ariad (NADSAQ: ARIA), however—ponatinib (Iclusig) was approved in December, three months ahead of schedule.
The Biotech Industry Organization (BIO) raised concerns about the FDA’s emphasis on parallel development of diagnostics and drugs in its comments to the draft guidance, worrying that the FDA guidelines don’t take into consideration the real-world stumbling blocks often in the way of such joint efforts. The trade association pointed out that it is not uncommon for development of the test and the companion drug to fall out of sync, or for a pertinent biomarker to not even be discovered until late in the development process, thus leaving the test’s development to late in the game.
William Goeckeler, head of oncology medical affairs at Boehringer, told me that certainly not all drugs, or all tumors, are amenable to companion diagnostics. The biology can be very tricky, and many tumors use multiple genetic pathways to grow and multiply. Nevertheless, he thinks in the future almost all cancer clinical trials will have a biomarker component that lends itself to a companion diagnostic. In fact, Boehringer started a major campaign in April, called “Let’s Test,” to educate oncologists and other health professionals about the value of testing their patients for biomarkers associated with their cancers.
“This is a very important area for us. We are really working on trying to incorporate diagnostics for biomarkers into the drugs we develop,” Goeckeler said. “This is transitioning into a commercial reality.”