The FDA has lifted the partial hold it dropped on AstraZeneca’s top pipeline drug durvalumab a month ago, allowing investigators to resume recruiting patients with head and neck cancer for two key late-stage trials.
Playing catch-up with Merck, Bristol-Myers Squibb and Roche, the partial hold in October rattled investors, raising a red flag that dragged the pharma giant a bit further behind in one of the most competitive R&D fields in biopharma. But regulators agreed to get the studies back on track with no change in protocols, evidently satisfied that the bleeding episodes that triggered the hold posed no special threat to others.
Head and neck cancer is often linked to bleeding episodes. In this case researchers have been studying both durvalumab — AstraZeneca’s great blockbuster hope — as well as tremelimumab in a solo and combo studies,
Resuming enrollment, though, isn’t just a matter of hanging an ‘open’ sign out in front of the clinic. While one of the trials called KESTREL has already begun to accept new patients at some sites, investigators will have to progressively roll out the renewed recruitment effort, with regulators and ethics committees first signing off in their respective jurisdictions where required.
Soon after AstraZeneca was forced to hit the brakes on head and neck cancer, Merck gained an approval for the use of Keytruda for that indication. That quickly killed any remaining hopes AstraZeneca may have had for a quick OK of durvalumab alone.
The pharma giant has been steadily readjusting its sights on the checkpoint market, falling far behind rivals. Its major hope now lies in gaining combination OKs that can give it a quick, though perhaps short-lived, commercial edge. The company has experienced a series of painful setbacks over the past year which has been slowly killing expectations that AstraZeneca can ever live up to the bright picture CEO Pascal Soriot painted for investors more than two years ago.
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