-=Verastem (VSTM) wins FDA approval for first cancer drug

The FDA has approved Needham biotech Verastem Oncology's first drug, a treatment for multiple types of blood cancer.

The FDA on Monday gave the green light for sales of Copiktra, an oral medication designed to block two types of enzymes that fuel the growth and survival of malignant white blood cells. The drug has been approved for use in multiple types of blood cancers, including chronic lymphocytic leukemia and small lymphocytic lymphoma.

The approval marks a major win for Verastem (Nasdaq: VSTM), which licensed the drug — whose generic name is duvelisib — from Cambridge biotech Infinity Pharmaceuticals in 2016 after disappointing trial results.

Verastem's Phase 3 trials, however, showed that patients taking Copiktra survived longer without the disease worsening compared to a "standard of care" drug sold by Novartis, the company reported last year. Copiktra's approval is as a third line therapy, and close to 65 percent of clinical trial participants experienced side effects ranging from rashes to infection.

Copiktra is the first product Verastem has brought to market. The biotech previously had laid off half of its workforce in 2015 after halting development of a drug for a severe form of lung cancer.

Trading in Verastem shares was halted prior to the approval announcement around 2:30 p.m. Monday, and did not reopen before markets closed.

Verastem has set a $11,800 monthly cost for the twice daily pill, which is expected to be available later this week.

It is estimated that some 350,000 patients in the U.S. have the various forms of leukemia and lymphoma that could be targeted by copiktra, according to the company.