MSD’s Keytruda/chemo combo scores first-line FDA approval in NSC lung cancer

pharmafile | November 1, 2018 | News story | Sales and Marketing Cancer, MSD, NSCLC, keytruda, lung cancer, pharma 

MSD’s blockbuster anti-PD-1 immunotherapy has secured another FDA approval, it has emerged, in combination with carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

The US regulator’s decision was based on Phase 3 data which demonstrated significant overall survival benefit of Keytruda regardless of the tumour PD-L1 expression status of a patient, with it found to reduce the risk of death by 36% compared to chemotherapy alone.

MSD said that the approval was the first of its kind, making the Keytruda/chemo combo the only anti-PD-L1 regimen authorised in squamous NSCLC regardless of tumor PD-L1 expression status.

“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,” explained Dr Balazs Halmos, Director of the Multidisciplinary Thoracic Oncology Program at the Montefiore Einstein Center for Cancer Care, as well as 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.”

MSD President Dr Roger M Perlmutter also remarked: “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. Approval by the FDA has the potential to mean that Keytruda can be used to improve survival for more patients with this debilitating disease.”

Matt Fellows

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