Pfizer snags OK for Xalkori follow-up Lorbrena in its 3rd cancer approval in 2 months

Pfizer’s oncology unit is on a roll. On Friday, the FDA approved its third cancer-fighter from the New York drugmaker in the past two months, setting it up to mount a double-barreled challenge in ALK-positive non-small cell lung cancer.

The latest green light comes for targeted lung cancer Lorbrena, a successor to Pfizer’s Xalkori, which treats lung cancer patients with abnormal ALK genes. And the drugmaker's hoping its newcomer—priced at $16,055 per month, according to a Pfizer spokeswoman—can help back up the older drug, which has been pummeled as of late by new competition.

Xalkori is now vying in the previously untreated ALK-positive market with both Alecensa—which topped it in a head-to-head trial—and Zykadia. And soon, Takeda’s Alunbrig, which already boasts a second-line nod, could make its front-line debut; it posted positive data in untreated patients this July, following up with a big Xalkori head-to-head win in September. And Xalkori’s sales have retreated in response. In the first half of this year, its top-line contribution declined to $290 million from $296 million year over year.

For now, Lorbrena will come at least second in line after prior therapies; it's approved to treat ALK-positive NSCLC after Xalkori and at least one other ALK inhibitor have failed, or as a second-line-treatment after Roche’s Alecensa or Novartis’ Zykadia. Pfizer is testing Lorbrena in the first-line setting, where earlier use would put it on even footing with rivals and offer a top-line boost.

Lorbrena's go-ahead is a conditional one, meaning the FDA will be looking to additional trials from Pfizer to confirm the benefits seen in a positive phase 1/2 study. But in the meantime, "we believe that Lorbrena will benefit" patients with ALK-positive tumors, which affect about 3% to 5% of NSCLC patients, Andy Schmeltz, global president of Pfizer Oncology, said in a statement.

Meanwhile, the New York pharma giant is also trialing Lorbrena alongside immuno-oncology agent Bavencio, a member of the PD-1/PD-L1 class that it shares with Merck KGaA. At this year’s American Society of Clinical Oncology annual meeting in Chicago, results showed that while a Bavencio-Xalkori combo wasn’t well-tolerated, a Bavencio-Lorbrena pairing "had a reasonable safety profile along with signs of efficacy, including a 46.4% objective response rate," Credit Suisse analyst Vamil Divan wrote to clients at the time.

"We find the prospect of a PD-(L)1 + ALK TKI combination intriguing, particularly as this would represent a rare corner of the oncology market where Bavencio may have an advantage, in both data quality and timing," Divan added.

Lorbrena is the third recent drug in Pfizer’s stable to make its way into the FDA’s good graces. In September, the company snagged an approval for another targeted lung cancer med, EGFR-focused Vizimpro, and clearance for PARP inhibitor Talzenna followed in mid-October.