Regulatory, Setbacks

Roche, AbbVie forced to slam brakes on myeloma studies of star drug Venclexta after researchers flag higher risk of death

Two heavyweight pharma players today said they’ve been forced to stop recruiting patients for all ongoing studies involving Venclexta (venetoclax) for multiple myeloma. Roche and AbbVie say the drug arm has been linked to a higher rate of death than the control group, prompting the FDA to issue a partial hold ordering them to suspend any new patient recruitment for the blood cancer trials until they can sort out what is happening.

In the study, 21.1% — 41 of 194 patients — in the venetoclax arm compared with 11.3% — 11 of 97 patients — in the placebo arm died, creating a hazard ratio of 2.03.

Michael Severino

Initially stamped with an accelerated approval for CLL back in 2016, this drug has been hurried along by the FDA with a total of 5 breakthrough drug designations. Both companies are credited with top investigative teams and a keen interest in the oncology market.

The sudden halt on recruitment will likely put a crimp in their plans to hit $3 billion in peak sales for the drug, which was initially limited to patients with a 17p deletion, accounting for about 10% of all cases. Last summer they got an approval to use the drug with Rituxan for relapsed CLL, an add-on that Leerink’s Geoffrey Porges estimated could be worth $690 million this year alone.

This was the Phase III BELLINI trial (M14-031), one of dozens of ongoing clinical trials that the pharma giants are pursuing for this therapy, according to a quick check of

“We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program,” said AbbVie research chief Michael Severino in a prepared statement.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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