In a blow to its product pipeline, the drug maker yanked regulatory submissions for its experimental drug Zactima plus chemotherapy as a treatment for lung cancer. AstraZeneca had filed the combo as a treatment for advanced non-small cell lung cancer (NSCLC) with the FDA and EU authorities in June, and previously touted Zactima as an important new filing this year.
The decision follows an updated analysis that demonstrated no overall survival advantage when Zactima was added to chemotherapy. Regulators also said the existing package of clinical data, which used progression-free survival rather than overall survival as the primary end point, might may not be sufficient for approval (here's the statement).
Zactima earlier this month was named by Fitch Ratings as one of AstraZeneca's "promising" products being prepared for launch, The Wall Street Journal notes. The ratings agency poined out that AstraZeneca needs new products to compensate for patents due to expire on many drugs. However, in an investor note, LeerinkSwan analyst Seamus Fernandez writes this is a "slight negative," because AstraZeneca "AZN management has not emphasized Zactima as core to its business."