UPDATE: The FDA last Friday approved Roche/Genentech's Alecensa (alectinib) for the treatment of ALK-positive non-small cell lung cancer (NSCLC) for patients with the disease refractory to therapy with Pfizer's Xalkori. The approval comes well before the drug's March 2016 PDUFA date.
This marks the agency's 42nd newly approved medication this year, topping a banner 2014 that saw 41 new drug approvals. Alecensa is expected to eventually become a blockbuster treatment for Roche.
According to the IMS, there will be a continuing flurry of drug approvals over the next four years (225, to be exact, and most of them in cancer-related therapeutic spaces).
- The FDA has approved 41 new drugs so far this year (UPDATED ABOVE), matching the total number of approvals in 2014. With 23 days left in the year, the FDA has a chance to set a new record for total new-product approvals in one year.
- At the same time, the biotech index is faltering. It's up 8.2% this year—below the range of 12% to 64% growth over the past six years.
- Although the biotech index is down, many analysts have long felt the biotech index is overvalued.
Yesterday's approval of Alexion's Kanuma marked #41 for the year. Recently, the FDA has been on a tear, approving eight new products in November. With 23 days left in the year, one more approval to tip the FDA into record territory will likely be forthcoming, with PDUFA dates for therapies by Eagle Pharmaceuticals, Merck, and AstraZeneca scheduled in December (UPDATED ABOVE). The question now is: Just what will 2015's final number be?
As for the biotech index, sepculative companies have fallen out of favor. Looking back to late September when the market was down 313 points in a day, the Nasdaq Biotechnology Index was down a whopping 6.3%. As outrage continues against high drug prices, biotech companies may be more muted in the near term given the typically high prices their products command.