Pfizer extends cancer drug approval streak with OK for Lorbrena
- The Food and Drug Administration has approved Pfizer's Lorbrena as a second-line therapy for patients with ALK-mutated non-small cell lung cancer (NSCLC), handing the pharma giant its third cancer drug OK in the past two months.
- Lorbrena will come to market under an accelerated approval based on results from a Phase 1/2 study, which showed treatment with the drug led to a 48% overall response rate in patients previously treated with one or more other therapies.
- A tyrosine kinase inhibitor (TKI), Lorbrena helps to bolster Pfizer's lung cancer franchise as the drugmaker's older TKI Xalkori faces stiff competition from a rival marketed by Roche. The approval also follows recent OKs for Pfizer's Talzenna and Vizimpro.
Pfizer was first to market with a TKI for ALK-positive NSCLC, winning FDA approval for Xalkori (crizotinib) in 2011.
Since then several others have come to market, led by Roche's Alecensa (alectinib), which bested Xalkori in a head-to-head study that read out last summer. Takeda's Alunbrig (birgatinib) recently did the same, surpassing Pfizer's drug in extending progression-free survival among previously untreated ALK-positive NSCLC patients.
Treatment of NSCLC more broadly has shifted markedly since 2011 due to the advance of immunotherapies like Merck & Co.'s Keytruda (pembrolizumab).
But patients with ALK or EGFR mutations are still frequently treated with TKIs. (Keytruda, while approved for first-line NSCLC treatment, is only OK'd for use in those narrower patient populations after disease progression following TKI therapy.)
Xalkori, meanwhile, is starting to lose steam commercially. Global sales of the drug totaled $127 million in the third quarter of 2018, a 13% fall from $146 million during the same period a year prior. Lorbrena (lorlatinib), then, could help Pfizer extend its market share in patients whose tumors have continued to grow after initial treatment.
"Building upon our extensive understanding of tumor complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors," said Andy Schmeltz, head of Pfizer Oncology, in a Nov. 2 statement.
Lorbrena's approval also extends a productive fall for Pfizer.
In September, the FDA approved Vizimpro (dacomitinib), a drug targeting EGFR-mutated NSCLC. This was closely followed by an approval for Pfizer's PARP inhibitor Talzenna (talazoparib) two months ahead of the expected decision date from the FDA.
Talzenna is OK'd specifically for patients with BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.
- BioPharma Dive An early approval puts Pfizer's Talzenna in a crowded field
- BioPharma Dive Cancer drug approval expands Pfizer's targeted therapy ambition
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