FDA OKs First Cancer Drug by Genetic Type according to : WebMD

So on Tuesday, the U.S. Food and addiction Administration announced that, for the first time, it had approved a cancer drug based on disease genetics rather than the body part where the cancer originated. The drug had previously received separate approval for a variety of tumor types, such as metastatic non-small cell lung cancer, metastatic melanoma, and other cancers. "We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location." "Until now, the FDA has approved cancer treatments based on where in the body the cancer started -- for example, lung or breast cancers," said Pazdur, who also directs the FDA's Oncology Center of Excellence. By Randy DotingaHealthDay ReporterWEDNESDAY, May 24, 2017 (HealthDay News) -- Many new cancer drugs target genetic "biomarkers" that are specific to tumors -- wherever in the body they may appear.




It is the first time the agency has approved a cancer treatment based solely on a genetic biomarker. "We have now approved a addiction based on a tumor's biomarker without regard to the tumor's original location." It was previously approved to treat advanced melanoma, advanced non-small cell lung cancer, head and neck cancers and classical Hodgkin lymphoma. The approval covers patients whose cancer has progressed despite prior treatment and those who have no satisfactory alternative treatment options. "Until now, the FDA has approved cancer treatments based on where in the body the cancer started - for example, lung or breast cancers," said Richard Pazdur, head of oncology products for the FDA's Center for Drug Evaluation and Research.

FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug

Panelists thought that the use of the addiction should be limited to women who have taken the breast cancer drug Herceptin within the past two years. Puma argued today that taking other drugs can reduce the severity of that diarrhea. that in patients whose tumors tested positive for both HER2 and the estrogen receptor (called ER+). The drug, neratinib, was tested to see if it would prevent breast cancer from recurring after women are in remission in women whose tumors test positive for a receptor called HER2. A panel of experts convened by the Food and Drug Administration says that a drug for breast cancer developed by Puma Biotechnology should be approved, but argued for more limits on which women should get the medicine.


collected by :Lucy William

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