Drug Development, FDA

Pfizer wins a “breakthrough” title for ALK/ROS1 contender lorlatinib after hustling into PhIII

Mace Rothenberg, Pfizer

Last June at ASCO, Pfizer researchers were happy to discuss the positive human data they had plumbed for lorlatinib (PF-06463922), their “next-generation” ALK/ROS1 tyrosine kinase inhibitor. Hustling it into Phase II, Pfizer saw this program as a key part of its oncology story, which has played a major role in winning new respect for the pharma giant’s pipeline efforts.

Now the FDA is endorsing that sentiment, giving Pfizer its breakthrough drug designation for this drug — now in a pivotal trial — which could help further accelerate it along the pathway to a potential approval.

The BTD was provided for their work with ALK-positive metastatic non-small cell lung cancer, a huge focus in the clinic right now. Pfizer recently launched a Phase III second-line study dubbed CROWN to provide the pivotal data that would be needed for a marketing approval.

Pfizer has been pouring money into its cancer R&D work, picking up a PARP drug in its $14 billion Medivation buyout and recently winning an approval for the checkpoint inhibitor avelumab, partnered with Merck KGaA in a record $850 million upfront deal.

The FDA’s oncology division, meanwhile, has embraced the BTD program in the last few years, rapidly accelerating reviews and approvals for the latest wave of cancer therapies to hit the market.

“This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK-positive NSCLC whose cancers have progressed despite treatment. Pfizer’s rapid development of lorlatinib reflects a commitment to developing biomarker-driven therapies to meet the evolving needs of patients,” said Mace Rothenberg, chief development officer for oncology Pfizer. “We look forward to working with the FDA to accelerate the development of this therapy.”


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