Regulatory

Verastem takes AbbVie’s blood cancer castoff to the FDA

A blood cancer drug that’s passed through the hands of several companies – disappointing drugmakers along the way – is finally headed to the FDA. Verastem $VSTM, a company near Boston, has filed for approval of duvelisib, a pill that blocks the well-known cancer target PI3 kinases.

The drug is meant as a treatment for patients who have blood cancers chronic lymphocytic leukemia, small lymphocytic lymphoma, or follicular lymphoma.

Robert Forrester

Duvelislib has a nomadic past, traveling from Intellikline, where it was originally discovered, to Infinity in 2010. Then in 2014, AbbVie paid $275 million in an upfront deal to co-develop the drug but was disappointed in the results. AbbVie ended up walking away from the deal, while Infinity axed 100 staffers and shuttered trials. Duvelislib then came to Verastem at no upfront cost to the company.

Verastem presented Phase III data on the drug at ASH last year, trumpeting statistical significance on progression-free survival. But it flunked the key overall survival secondary endpoint and failed to do any better than Genmab’s monoclonal antibody Arzerra in extending the lives of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Still, positive data showed a median PFS of 13.3 months versus 9.9 months for the control. This is the data Verastem is now hustling to the FDA, looking for an approval to treat second-line cases.

“Oral duvelisib is the first PI3K inhibitor to show efficacy as a monotherapy in a randomized Phase III study in patients with relapsed or refractory CLL/SLL,” said Robert Forrester, president and CEO of Verastem, in a statement. “Duvelisib monotherapy has also demonstrated significant clinical activity in patients with double-refractory follicular lymphoma. We believe duvelisib will offer a convenient oral treatment alternative.”

The company said it expects to hear from the FDA in early 2019.


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