Protocols

Roche scores a success for Alecensa PhIII; FDA schedules AdComm for Heplisav-B; New CMO at Sarepta

Sandra Horning

Roche reported this morning that its latest Phase III study for Alecensa (alectinib) came through, hitting the endpoint on progression-free survival for non-small cell lung cancer patients who had failed chemo combined with crizotinib. “We are pleased to announce that the results of the phase III ALUR trial further support the use of Alecensa as a treatment for people with ALK-positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options,” said Sandra Horning, Chief Medical Officer and Head of Global Product Development. “The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster.”

Dynavax is getting an AdComm for Heplisav-B, a hepatitis B vaccine. The meeting is scheduled for July 28, just days ahead of its August 10 PDUFA date, which could pose a problem. “The notification of a VRBPAC meeting comes as no surprise and thus we are prepared for it,” said Eddie Gray, chief executive officer of Dynavax. “The company looks forward to continuing to work with the FDA through the review process and discussing HEPLISAV-B with the advisory committee.”

→ Now that Ed Kaye has solidly ensconced himself in the CEO’s office at Sarepta, he’s handing over his old CMO title to Catherine Stehman-Breen, who most recently had been head, clinical project management and operations at Regeneron. For the 12 years before that she had been at Amgen, where she had been vice president, global development, leading the neuroscience, nephrology and bone therapeutic areas. Sarepta sells a controversial drug for Duchenne muscular dystrophy.

→ San Diego-based Tocagen has set terms for its IPO, looking to raise about $80 million through the sale of 7.3 million shares at $10 to $12 each.


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