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FDA approves Alecensa for ALK-positive NSCLC
The FDA today approved alectinib to treat patients with metastatic ALK-positive non–small cell lung cancer whose disease has worsened after — or who could not tolerate treatment with —crizotinib.
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
Richard Pazdur
Alectinib (Alecensa, Genentech) — administered orally — blocks the activity of the ALK protein which may prevent NSCLC cells from growing and spreading.
The FDA based its approval in part from safety and efficacy data from two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer maintained by treatment with crizotinib (Xalkori, Pfizer).
Participants received alectinib twice daily. Thirty-eight percent of participants in the first study experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for a median of 7.5 months.
Forty-four percent of participants in the second study experienced a partial shrinkage in their tumors, lasting a median of 11.2 months. Additionally, 61% of participants in both trials who had measureable brain metastases experienced a complete or partial reduction in their brain tumors, lasting a median of 9.1 months.
The FDA warns doctors that alectinib may cause serious adverse events such as liver problems and life-threatening lung inflammation.
Perspective
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We have heard multiple reports about this drug and its efficacy at meetings over the past few years, and some of those studies have since been published.
The efficacy speaks for itself. It is a very highly potent ALK inhibitor and it is going to be a big benefit for our patients. What is unique about this drug is its toxicity profile, which is considerably less than that of ceritinib (Zykadia, Novartis), which already is approved for treatment of ALK-refractory patients. With the activity seen in what has been presented thus far and its much more tolerable profile, I think alectinib is anxiously awaited by everyone who treats patients with lung cancer.
This agent is particularly important given the segment of the patient population that continues to progress on or cannot tolerate crizotinib (Xalkori, Pfizer). We are finding we can actually treat patients in sequence with these drugs. We are getting closer to being able to treat patients with one drug after another to make this more like a chronic disease than something that has a defined terminal endpoint. By having more drugs in this arena, we are finding that patients can use many of these drugs over time, which helps to improve their quality of life and their duration of life.
The activity alectinib has shown in the brain also is very exciting. Ceritinib shows activity in the brain, but alectinib does it with more tolerability. These patients often progress in the brain and have limited treatment options, so drugs that can go to the brain and cause tumor shrinkage in the brain again helps with quality of life and duration of life, and it is really remarkable to be able to treat a patient’s brain without things like radiation.