U.S. health regulators on Friday said they have granted accelerated
approval to Roche Holding's drug for advanced lung cancer in patients
with a specific genetic mutation. The drug, alectinib, to be sold under the brand name Alecensa, was
approved to treat patients with advanced ALK-positive non-small cell
lung cancer (NSCLC) whose disease has worsened after, or who could not
tolerate, treatment with Pfizer's Xalkori.
"Today's approval provides a new therapy for a group of patients who
would have few treatment options once their disease no longer responds
to treatment with Xalkori," Richard Pazdur, head of the Food and Drug
Administration's Hematology and Oncology Products division, said in a
statement.
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