A 2009 collaboration agreement with Pfizer could start bearing fruit for Abbott Molecular by year end, with the firms' lung cancer drug-diagnostic combination now under review at FDA.

Abbott announced a PMA submission for its ALK FISH assay May 23, about a week after Pfizer announced that FDA had accepted a new drug application and granted six-month priority review for crizotinib, an agent intended to target the 3%-5% of patients with non-small-cell lung cancer who have a rare genetic rearrangement.

The timing is not coincidental. Pfizer tasked the Abbott unit in 2009 to develop a fluorescent in situ hybridization, or FISH, assay to detect the relevant genetic aberration targeted by crizotinib, specifically the EML4-ALK fusion gene. The resultant test is being employed in Pfizer's ongoing phase III study, which has generated data for both Pfizer's NDA and Abbott's PMA.

If the combination is approved, Pfizer and Abbott will establish a joint committee to oversee the total marketing effort, although Abbott will do most of the marketing.

Abbott expects a simultaneous FDA decision on the drug and assay. If approval is granted, the collaboration will continue in the marketing efforts for the drug-diagnostic pairing. While Abbott will take on the lion's share of responsibility for marketing the test, the two firms will establish a joint committee to oversee the total marketing effort, according to an Abbott spokesman.

Abbott Test Joined Pfizer Program At Phase III

The crizotinib development program has proceeded with almost unprecedented speed. The EML4-ALK fusion gene was identified as a key factor in a small subset of lung cancer patients in 2007. Pfizer reported what was widely regarded as highly positive phase I data in 2010: a 90% response rate in patients who tested positive for the gene.

From there, the firm jumped right to a pivotal phase III trial and submitted a "rolling" NDA to FDA in January.

While patients in the earlier-stage trial were tested for the EML4-ALK fusion gene, Abbott's FISH assay entered Pfizer's crizotinib clinical program at the start of the phase III study, where it is the only test being employed.

Enrollment is still open, but some data have already been submitted to FDA from the phase III trial, which makes up an important component of Abbott's submission.

Co-Development Catalyst?

FDA has already approved a collection of so-called companion diagnostics to help drive patient selection or dosing for a drug – among them, Abbott's PathVysion FISH assay for selecting breast cancer patients for treatment with Roche's Herceptin (trastuzumab). But the Pfizer-Abbott project is a rare example of drug and diagnostic companies closely collaborating on development and marketing of the products.

In that regard, it is an early test of FDA's evolving policy for drug/diagnostic co-development, in which the agency puts significant emphasis on drug and diagnostic sponsors working very closely together and developing the products on parallel timelines.

"Sometimes in order to make forward progress you need a catalyst," said Mace Rothenberg, a Pfizer oncology executive, at a press briefing last October. "I think crizotinib is that catalyst to really allow us to understand a regulatory pathway for bringing diagnostics and therapeutics forward together."

By David Filmore

Abbott Follows Pfizer To FDA With Co-Developed Lung Cancer Diagnostic

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