Earlier this year, the giant New Jersey based pharma firm Merck & Co. tried, but failed, to get accelerated approval from the US Food and Drug Administration for the use of Keytruda in cases of triple negative breast cancer (TNBC). The setback may be a sign that the FDA is hardening its line against quick approvals for what are known as immuno-oncology agents.
In many breast cancers, the cells in the tumors have one or more of three receptors that make them vulnerable to chemotherapy. In the case of triple-negative breast cancer, on the other hand, treatment is complicated by the absence of any of the receptors. It makes chemo a smaller part of the overall treatment, and makes surgery a larger part. Merck wanted to sell Keytruda as part of the chemo that both precedes and follows surgery in TNBC situations.
In late February, a panel of ten experts unanimously ruled that Merck must wait for longer-term data from its trial before asking the FDA for approval.
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Keytruda is the brand name — the chemical name is pembrolizumab. It is used at present on many forms of cancer. It is, for example, a first-line treatment for metastatic non-small cell lung carcinoma. The Merck now has a sizeable investment riding on its availability for TNBC and will presumably continue pressing the point if the further trial results allow.