FDA Approves Genentech’s Alecensa as First-line Therapy for ALK-positive, Advanced NSCLC

FDA Approves Genentech’s Alecensa as First-line Therapy for ALK-positive, Advanced NSCLC
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OATD-01 Phase 1 trial

The U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib), by Genentech, as a front-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).

Results from a Phase 3 trial supported the agency’s decision, made to a supplemental New Drug Application (sNDA) filed by Genentech. The agency also raised to full approval — from accelerated approval granted in 2015 — the use of  Alecensa by patients with ALK-positive metastatic NSCLC whose disease as progressed on Xalkori (crizotinib) or have become intolerant to that treatment.

Approximately 3 to 7 percent of NSCLC patients show a chromosomal rearrangement that leads to a fusion of the ALK gene with another gene. As a result, ALK is constantly activated, changing its normal function and ultimately inducing tumorigenesis (the development of tumors). In ALK-positive NSCLC metastatic patients, the cancer frequently spreads to the brain.

Alecensa, an oral medication, works against cancer by selectively inhibiting ALK activity.

Approval was based on results in the Phase 3 ALEX trial (NCT02075840), which evaluated the effectiveness and safety of Alecensa compared to Xalkori. The trial included 303 patients with ALK-positive NSCLC who had not received prior treatment for metastatic disease. ALK-positivity was diagnosed through a test developed by Roche Tissue Diagnostics, also recently approved by the FDA.

Patients were randomized to receive either Alecensa or Xalkori, and their progress was evaluated.

Researchers found that Alecensa treatment significantly reduced the risk of disease progression or death by 47% compared with those given Xalkori. Alecensa extended the median time that people lived without their disease worsening from 10.4 months (Xalkori cohort) to 25.7 months (Alecensa cohort).

Alecensa also lowered the risk of cancer to spread to or grow in the brain or central nervous system (CNS) by 84% compared to Xalkori, based on a time to CNS progression analysis.

The safety profile of Alecensa was consistent with previous studies. The most common side effects reported included tiredness, constipation, swelling, and low red blood cell count. Patients receiving Alecensa  also experienced fewer side effects than those given Xalkori.

“Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” Sandra Horning, chief medical officer and head of Global Product Development at Genentech, said in a press release.

“In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib [Xalkori] and also showed a marked reduction in the risk of their cancer spreading to the brain,” Horning added.

Alecensa previously was granted priority review  and designated a breakthrough therapy by the FDA for the treatment of patients with ALK-positive NSCLC who have not received previous treatment with an ALK inhibitor. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

Genentech is a member of the Roche Group.

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