The U.S. Food and Drug Administration (FDA) gave a conditional approval for Genentech's lung cancer experimental drug called Alecensa. The drug is targeted for patients with certain types of lung cancer who have little options left.
Genentech's Alecensa drug won FDA's accelerated conditional approval to treat patients with advanced non-small cell lung cancer with anaplastic lymphoma (ALK) gene mutation. An ALK gene mutation indirectly causes the cancer tumors to grow.
The lung cancer patients experienced a relapse after using Pfizer Inc.'s Xalkori drug or those who failed to tolerate it. The FDA gives an accelerated approval to medicines that prove positive, beneficial results to patients with life-threatening or grave medical conditions.
"Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib," said Genentech's Global Product Development head and chief medical officer Dr. Sandra Horning.
Genentech was given a conditional approval. In order to maintain it, the drugmaker must proceed with additional tests to confirm the projected benefits. Genentech began a bigger study that placed Alecensa with Xalkori in direct comparison.
The goal is to prove how long Alecensa can extend patient survival compared to its competitor. Patients who had not been given either drug were employed in the study.
In one study, which led to the drug's accelerated conditional approval, Alecensa reduced the tumors of about 38 percent of the patients in the 87-participant study. The tumor shrinkage lasted seven and half months on average.
In another Genentech-funded study, Alecensa reduced lung tumors of 44 percent of the 138 patients with benefits lasting a median of 11 months. These patients previously took Xalkori.
The two studies also analyzed Alecensa's effect on brain tumors. The FDA said 61 percent of all patients in both studies showed reduction in brain tumor with a median lasting effect of nine months.
"In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand," said Dr. Richard Pazdur from the FDA.
