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Merck & Co.'s Keytruda wins 5 new approvals in Japan

Japan's Pharmaceuticals and Medical Devices Agency granted five approvals to Merck & Co. Inc.'s blockbuster drug Keytruda, including a new indication and expanded use in treating lung and skin cancers.

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The Kenilworth, N.J.-based company said in a Jan. 3 press release that a combination of Keytruda, Eli Lilly and Co.'s Alimta and platinum-based chemotherapy drugs cisplatin or carboplatin has been approved by the Japanese regulator as an initial treatment of patients with advanced nonsquamous non-small cell lung cancer, or NSCLC, that has returned and cannot be removed through surgery.

Keytruda plus chemotherapy drugs carboplatin and paclitaxel or nab-paclitaxel also received approval as an initial treatment of patients with advanced squamous NSCLC that has returned and cannot be removed through surgery. Both combination treatments were approved regardless of PD-L1 expression. The PD-L1 protein helps the disease avoid the body's immune system.

The Japanese regulator further approved Keytruda as a single therapy for the initial treatment of advanced PD-L1-positive NSCLC that has returned and cannot be removed through surgery.

Keytruda was approved as an adjuvant therapy — or a medicine given after the initial therapy — for melanoma, the most serious type of skin cancer.

Merck said the cancer drug received Japanese approval to treat a new type of cancer as well. Keytruda, along with a companion diagnostic test kit by Japanese healthcare services company Falco Holdings Co. Ltd., was approved for use to detect and treat advanced microsatellite instability-high, or MSI-H, tumors that worsened after chemotherapy.

In MSI-H tumors, the cancer cells have a larger number of genetic markers known as microsatellites — short, repeated sequences of DNA — which may cause defects in the ability to correct mistakes that occur during DNA replication.

The Pharmaceuticals and Medical Devices Agency had granted priority review to Keytruda in these indications, Merck said.