Verastem wins FDA approval for blood cancer drug
Needham-based Verastem Oncology won its first drug approval Monday, a medicine that treats three forms of blood cancer.
The Food and Drug Administration approved Copiktra to treat chronic lymphocytic leukemia and small lymphocytic lymphoma in adult patients who relapse or don’t get better as a result of at least two prior therapies.
The agency also approved it for adult patients with follicular lymphoma who have already been treated with at least two other therapies.
Lymphoma is the most common type of blood cancer. The forms that Copiktra will treat are common indolent non-Hodgkin lymphomas. There are an estimated 681,000 people living with non-Hodgkin lymphoma in the United States alone. Many of these patients will eventually relapse or develop resistance to other treatments.
“Patients living with [these diseases] are in need of additional treatment options, and new therapies such as Copiktra are crucial because each patient’s treatment journey is unique,” said Meghan Gutierrez, chief executive officer of the Lymphoma Research Foundation. She said she hopes that such drugs help make lymphoma a disorder that can be “managed as a chronic disease — and eventually cured.”
The new medicine will carry a boxed warning because of a risk of fatal or serious side effects, including infections, diarrhea, and lung inflammation.
Verastem, which was founded in 2010, has about 165 employees. The company’s share price rose nearly 2.8 percent when the Nasdaq suspended trading in the mid-afternoon, closing at $8.89.