Roche's Alecensa® Receives NMPA Approval in China for Adjuvant Treatment of Early-Stage ALK-Positive NSCLC

Jul 08, 2024 11:53 CST Updated 11:53

Roche

Oncology Drug Research, Development, and Manufacturing

Recently, Roche Pharmaceuticals, a multinational enterprise in Zhangjiang, Anshengsha^®(General name: Alectinib Hydrochloride Capsules) has been approved by the China National Medical Products Administration (NMPA) for a new indication, used as adjuvant treatment post-surgery for patients with anaplastic lymphoma kinase (ALK)-positive Stage IB to Stage IIIA non-small cell lung cancer (NSCLC).

In 2018, Alectinib was approved in China as a monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer. The approval of the adjuvant treatment indication for early-stage lung cancer marks Alectinib as the first ALK tyrosine kinase inhibitor (ALK-TKI) in China to cover both early and late stages, meaning that Chinese patients with ALK-positive lung cancer now have targeted therapies available from early to advanced stages, bringing them one step closer to a cure.

For patients with ALK-positive early-stage NSCLC, the peak period of recurrence is within two years after surgery, and recurrences are mostly distant metastases. The previous standard adjuvant treatment regimen was adjuvant chemotherapy, but the benefits were not ideal, with nearly half of early-stage NSCLC patients still experiencing disease recurrence post-surgery.The approval of this new indication for Alectinib has filled the gap in the treatment of early-stage ALK-positive lung cancer in China.

Professor Wu Yilong from Guangdong Provincial People's Hospital stated: "There has been a significant unmet need for adjuvant treatment of ALK-positive early-stage NSCLC post-surgery. The approval of alectinib's new indication has given clinical doctors strong confidence, potentially helping more ALK-positive early-stage lung cancer patients in China. With the new indication now available in China, the treatment landscape for ALK-positive early-stage NSCLC may undergo a major transformation."

Source: Roche Pharmaceuticals

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