Roche group Genentech’s Alecensa has been given a speedy US approval for a particular type of non-small cell lung cancer (NSCLC), giving patients access to a new targeted treatment option.
The US Food and Drug Administration has approved Alecensa (alectinib) for patients with anaplastic lymphoma kinase (ALK)-positive, metastatic NSCLC who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib). ALK gene mutations are present in about 5 percent of patients with NSCLC.
Approval came on the back of clinical data showing that the drug was able to shrink tumours after the disease was no longer controlled by Xalkori. In the first study, 38 percent of participants experienced a partial shrinkage for an average of 7.5 months. In the second study, 44 percent of experienced a partial shrinkage, lasting for an average of 11.2 months.
The trials also examined the drug’s effect on brain metastases, which is common in this population. Sixty-one percent in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumours, lasting an average of 9.1 months.
Safety wise, the most common side effects linked with the drug are fatigue, constipation, swelling and muscle pain, but Alecensa can also cause serious adverse events such as liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems, the FDA noted.
Given that Alecensa has been cleared via the accelerated approval pathways, a confirmatory study will be required to further explore and verify its clinical benefit, the regulator said.