Roche lung cancer blockbuster wins approval in early-stage NSCLC

19 Apr 2024
www.pharmamanufacturing.com
Drug ApprovalPhase 3Clinical ResultADC
Roche's Genentech announced that its blockbuster lung cancer treatment, Alecensa, has been approved for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), making it the first ALK inhibitorALK inhibitor approved in this indication.
The approval is based on positive results from the phase 3 ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.
According to Roche, about half of people living with early-stage NSCLC experience disease recurrence following surgery despite adjuvant chemotherapy; Alecensa can now address this unmet need.
Alecensa was first approved in late 2015 to treat people with advanced ALK-positive NSCLC whose disease had worsened after, or who could not tolerate treatment with tyrosine kinase inhibitor, Xalkori. Its approval was expanded in 2017, enabling the drug to be used as a first-line treatment for people with advanced ALK-positive NSCLC.
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