The Food and Drug Administration on Friday approved conditionally experimental Genentech drug for patients with certain types of lung cancer have few options.
Alecensa received accelerated approval for patients with advanced lung cancer with a mutation in a gene called ALK who have relapsed after treatment with Pfizer Inc. Xalkori or who could not tolerate the drug non-small cell. The mutation in ALK, anaplastic lymphoma kinase or indirectly promotes growth of tumors.
Accelerated approval is granted to drugs for serious or life-threatening diseases that show a likely effect that benefits patients. To maintain that conditional approval, the pharmaceutical should then do tests to confirm that the drug improves the condition of patients. Genentech has already begun a larger study of head to head how long Alecensa increases survival compared Xalkori Pfizer headquarters in New York, in patients not previously treated with a pill.
In one of two studies of patients midstage Alecensa that led to the approval, the pill twice a day reduced lung tumors in 38 percent of the 87 participants, and the benefits lasted an average of 7 and a half months. In a second study, also funded by Genentech, tumors shrank in 44 percent of the 138 participants, and the benefits lasted an average of about 11 months. All participants had previously taken Xalkori, but had stopped working.
Both studies also evaluated the effects of Alecensa, known chemically as alectinib, on tumors that had spread to the brain, which often occurs in these patients. According to the FDA, 61 percent of patients in both studies had their brain tumors shrink or disappear, with the effect that lasts about nine months on average.
"In addition to the primary effect of tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is a significant effect," Dr. Richard Pazdur, director of the Office of FDA Hematology and Oncology, said in a statement.
Alecensa is the only drug that manages to do that, according to a spokeswoman for Genentech.
Genentech, the biotechnology unit of Swiss drugmaker Roche Group, will be priced at around $ 12,500 per month before discounts negotiated with insurers. The company is offering financial help patients, including co-payment cards that allow patients with commercial insurance for the medication copay $ 25 a month.
Lung cancer is the leading cause of death from cancer at the National Cancer Institute US He estimates it will kill about 158,000 people this year. About 85 percent of lung cancers are small-cell carcinoma, which is usually diagnosed at an advanced stage, and about 5 percent of that group has the ALK mutation.
Alecensa can cause liver problems, potentially fatal inflammation of the lungs, the heart beats too slow and severe muscle problems. The most common side effects include fatigue, constipation, muscle pain and swelling in the hands, feet, ankles and eyelids.
Besides giving Alecensa an expedited review and accelerated approval, the FDA designated it as a very important therapy.
The drug will be available to patients in the United States within two weeks, Genentech said.