By Kirell Lakhman

Abbott Laboratories' Vysis ALK Break Apart FISH Probe Kit has won FDA clearance to detect rearrangements of the anaplastic lymphoma kinase, or ALK, gene in patients with non-small-cell lung cancer.

The test — which FDA cleared around one month ahead of schedule — is indicated to identify patients most likely to respond to the Pfizer drug Xalkori (crizotinib), which FDA also approved ahead of schedule.

It uses Abbott’s FISH technology to detect rearrangements of the ALK gene on the 2p23 chromosome.

The test and its companion drug — which was also approved around one month ahead of schedule — are both available "immediately through specialty pharmacies," Pfizer said.

Pfizer's drug is the first new lung-cancer treatment approved by the FDA in more than six years, and the first lung-cancer treatment ever to have been developed and approved with a companion diagnostic.

“The trend in oncology research continues towards targeted therapies," said CDRH chief Alberto Gutierrez. Abbott's test "is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases.”

Xalkori is indicated for patients with late-stage, non-small cell lung cancer with the rare mutation, and Abbott's companion diagnostic was cleared to help oncologists identify those patients — which comprise between 3 and 5 percent of all NSCLC patients, according to Abbott — that are most likely to benefit from it, Pfizer said.

However, FDA's assessment of the market could be a boon to Abbott. By its own reckoning, the agency said between 1 percent and 7 percent of patients with NSCLC — the most common form of all lung cancers — carry the ALK mutation.

Targeted therapies driven by companion diagnostics "are important options for treating patients with this disease and may ultimately result in fewer side effects,” according to Richard Pazdur, director of the Office of Oncology Drug Products in FDA’s Center for Drug Evaluation and Research.

For Abbot, the Pfizer alliance marks a breakthrough in the advancement of personalized medicine — and companion diagnostics specifically — that will help a subset of lung- cancer patients get treatment tailored to their unique genetic profile,” said Stafford O’Kelly, head of the drug maker's molecular-diagnostics business.

Xalkori, meantime, represents a new chapter in personalized therapy for lung cancer, enabling physicians to provide the right treatment for the right patient,” said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s oncology business unit.

Approved five weeks ahead of schedule, Xalkori was part of FDA’s accelerated-approval program that allows the agency to approve a drug to "treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients."

Xalkori was scheduled to be approved Sept. 30, while Abbott's companion diagnostic was originally to be cleared Sept. 28.

This means clinical labs that run molecular tests, and especially FISH-based ones, for physicians who are expected to prescribe Xalkori will have one month less to get their facilities up to snuff either to run the test in-house or send it out.

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