Newly Approved Drugs
Last week, the FDA approved pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma following progression on prior therapies. In the pivotal KEYNOTE-001 study, at the recommended dose for pembrolizumab of 2 mg/kg, the overall response rate was 24%, with a response duration lasting from 1.4 to 8.5 months.
Pembrolizumab is the first PD-1 inhibitor and sixth new melanoma treatment to gain approval since 2011.
To gain further insight into the approval of this novel agent, OncLive interviewed John Glaspy, MD, MPH, from the Jonsson Comprehensive Cancer Center and UCLA, where research into pembrolizumab was conducted.
F.D.A. Allows First Use of a Novel Cancer Drug
BY ANDREW POLLACK
The treatment unleashes the body’s immune system against tumors, and will initially be used against advanced melanoma.
Business Day
SEPT. 4, 2014
The Food and Drug Administration on Thursday approved the first of an eagerly awaited new class of cancer drugs that unleashes the body’s immune system to fight tumors.
The drug, which Merck will sell under the name Keytruda, was approved for patients with advanced melanoma who have exhausted other therapies.
Pfizer Inc’s Xalkori, which treats lung cancer patients with a specific gene mutation, proved effective in shrinking tumors in those with an even rarer form of the disease, according to data presented at a medical meeting on Saturday.
In the study of 50 non-small cell lung cancer patients with a rearrangement of the ROS1 gene, Xalkori treatment led to significant tumor shrinkage in 36 of them, or 72 percent, and halted tumor growth in an additional 9 patients, researchers reported