Roche lung cancer drug Alecensa gets rapid US approval
pharmafile | December 14, 2015 | News story | Sales and Marketing | Alecensa, FDA, Genentech, Roche, accelerated approval, alectinib, lung cancer, non-small cell lung cancer
The US health watchdog has approved Alecensa, a drug for people with certain types of non-small cell lung cancer manufactured by Genentech, a subsidiary of the Swiss pharma giant Roche.
The FDA granted accelerated approval for Alecensa (alectinib), for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer’s Xalkori (crizotinib).
Non-small cell lung cancer is a clinical area of huge pharma interest – with AstraZeneca, Pfizer and Lilly earning recent approvals in the UK, the EU and the US respectively. Other companies, including Merck and Pfizer, are investing heavily in late-stage trials of investigational immunotherapies for the disease, which accounts for the majority of all lung cancers. Genentech says lung cancer is “a major area of focus and investment.”
“We are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have three approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.”
The latest Roche approval comes after a rapid FDA review, which was based on tumour response rates and duration of response seen in the drug’s pivotal clinical trials. In the pivotal studies, Alecensa shrank tumours in up to 44% of people with ALK-positive NSCLC who progressed on Xalkori. In a subset of people with tumours that spread to the brain or other parts of the central nervous system, Alecensa shrank tumours in about 60% of people.
As a result of the accelerated approval, Roche says Alecensa will be available to people in the United States within two weeks. “Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib,” says Sandra Horning, chief medical officer and head of global product development. “Sixty percent of people enrolled in our studies had tumours that had spread to their central nervous systems, and Alecensa shrank tumours in many people in a subset of patients with CNS disease.”
Lilian Anekwe
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