Merck's Blockbuster Drug Keytruda Approved by FDA

New Delhi: Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the Keynote-407 trial. In the pivotal Phase 3 trial of patients regardless of a tumour PD-L1 expression status, Keytruda in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 per cent compared to chemotherapy alone. This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.

“Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Approval by the FDA has the potential to mean that Keytruda can be used to improve survival for more patients with this debilitating disease.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman.

“The results that support this approval from the Keynote-407 trial demonstrate the potential of Keytruda in combination with chemotherapy in patients with squamous non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Balazs Halmos, director of the multidisciplinary thoracic oncology program at the Montefiore Einstein Center for Cancer Care and director of clinical cancer genomics at the Albert Einstein College of Medicine. “With this important approval, more patients will have the opportunity to benefit from immunotherapy.”

Keytruda is the first anti-PD-1 approved in the first-line setting as both combination and monotherapy in certain patients with metastatic NSCLC. With this approval, all appropriate patients with metastatic squamous NSCLC and all appropriate patients with metastatic nonsquamous NSCLC and no EGFR or ALK genomic tumour aberrations are now eligible for a Ketruda-based regimen as their first-line treatment option.