FDA approves Roche’s new melanoma treatment
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that it had approved Roche’s Cotellic (cobimetinib), a treatment for patients with advanced metastatic melanoma that can’t be removed through surgery with a certain gene mutation (BRAF V600E or V600K). The drug is meant to be used in conjunction with vemurafenib.
“As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma.”
Perrigo gets FDA approval for generic KlorCon
DUBLIN — Perrigo on Wednesday announced that the Food and Drug Administration had approved the company’s generic KlorCon (potassium chloride) extended-release tablets.
The drug, which is indicated to treat and prevent hypokalemia, or low potassium levels, will be available in 600- and 750-mg dosage strengths. Sales of the drug for the 12 months ending Sept. 15 were $81 million.
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