Roche Gets Accelerated US Approval for Lung Cancer Drug
Marie de Vera | | Dec 12, 2015 01:21 PM EST |
(Photo : Reuters/Ally Song) Roche's drug called Alectinib will be sold under the brand name Alecensa.
U.S. health regulators have granted accelerated approval to Roche Holding's drug for advanced lung cancer in patients with a specific genetic mutation.
According to Reuters, the drug called Alectinib will be sold under the brand name Alecensa. It was approved to treat patients with advanced ALK positive non-small cell lung cancer (NSCLC) which has worsened can not be treated by Pfizer's Xalkori.
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"The approval today provides a new therapy for a group of patients who receive few treatment options because their body would no longer responds to treatment, like Xalkori," said by Richard Pazdur, head of the Food and Drug Administration's Hematology and Oncology Products division.
Xalkori is an advance treatment in the field of personalized medicine. It was designed to treat only patients with the ALK genetic mutation. Pfizer is also developing a drug for ALK positive patients who have stopped responding to Xalkori.
On the other hand, there are possible serious side effects with Alecensa, which includes liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. But, the most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids, according to Street Insider.
The FDA's Accelerated Approval Program permits the conditional use of the medical need in serious conditions based on the early evidence. The final approval of this medication if contingent based upon the results of clinical trials.
The drug, Alecensa will be available to people in the United States within two weeks. Genentech plan offers patient assistance programs for people taking Alecensa through Genentech Access Solutions. It is only available for those who qualify.
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