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Medicines licensing

Alectinib approved by FDA for ALK-positive lung cancer

Source: BSIP SA / Alamy Stock Photo

About 4-5% of non-small cell lung cancer patients are ALK-positive — the ALK subtype is the result of a chromosomal rearrangement that drives the formation of cancer

Alectinib, a new drug for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, has been approved by the US Food and Drug Administration (FDA).

Alectinib, marketed as Alecensa by Genentech, has been licensed for patients who cannot tolerate crizotinib or whose disease has worsened after treatment with the drug.

Alectinib was studied in two trials involving patients with metastatic disease for whom crizotinib, marketed as Xalkori by Pfizer, was no longer effective.

In the first study, 38% of patients had partial shrinkage of their tumours, lasting 7.5 months. In the second study, 44% of patients had partial tumour shrinkage lasting 11.2 months on average. For most patients, alectinib was effective at shrinking metastases in the brain, one of the most common places for lung cancer to spread.

About 4-5% of non-small cell lung cancer patients are ALK-positive — the gene mutation is usually found in younger patients with no or light smoking history. The ALK subtype is the result of a chromosomal rearrangement that creates a novel gene that drives the formation of cancer.

Crizotinib, the first drug to target ALK-positive lung cancer, was approved by the FDA in November 2013 and by the European Medicines Agency (EMA) in November 2012. Since the approval of crizotinib, ceritinib has also been approved in the United States and Europe, making alectinib the third drug to be licensed for the disease.

“[This] 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,” says Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA.

Alectinib is currently under evaluation by the EMA.

The main side effects associated with alectinib are fatigue, constipation, swelling and muscle pain.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20200358

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Supplementary images

  • Alectinib, a new drug for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (pictured), has been approved by the US Food and Drug Administration.

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