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Roche’s Alecensa Goes Up Against Zykadia with First-Line NSCLC US FDA Approval

 
• By Alexandra Shimmings

Expanded US approval for Alecensa in ALK-positive NSCLC will stand the product in good stead as it helps make up for upcoming biosimilar threat to Avastin, Rituxan and Herceptin.

Swimmers swimming in lanes
Alecensa has a competitive edge in ALK-positive NSCLC • Source: Shutterstock

The US FDA has approved an expanded indication for Roche’s second-generation anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib), which the company hopes will mean it can transform the standard of care for the treatment of people with ALK-positive metastatic non-small cell lung cancer (NSCLC). The drug is a key plank in the company’s defense against encroaching generic competition to its flagship products, Avastin (bevacizumab), Rituxan (rituximab) and Herceptin (trastuzumab).

The approval, based on the ALEX study, means it can be used upfront in patients with ALK-positive NSCLC as detected...

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