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Analyzing Recent Regulatory Approvals for Pfizer’s Oncology Drugs

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Apr. 12 2019, Published 11:05 a.m. ET

Lorbrena’s approval

On November 2, Pfizer (PFE) issued a press release announcing the FDA’s approval of Lorbrena, a third-generation TKI (tyrosine kinase inhibitor), in second-line plus ALK-positive (anaplastic lymphoma kinase) metastatic NSCLC (non-small cell lung cancer) indications in which patients have been previously treated either with Xalkori or at least one ALK inhibitor therapy.

According to the press release, in 2011, Pfizer launched the first TKI targeting ALK-positive metastatic NSCLC, Xalkori, in the US market. While the diagnosis rate for this cancer was 1% in 2011, it had increased to 80%–90% as of the end of 2018. Pfizer aims to target the underserved market opportunity—including patients who have seen disease progression after being treated with second-generation ALK TKIs—with Lorbrena.

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Regulatory milestones

On March 1, Pfizer issued a press release announcing the positive recommendation of the Committee for Medicinal Products for Human Use for Lorviqua (called Lorbrena in the United States) in second-line plus ALK-positive metastatic NSCLC indications in which patients have been previously treated either with Xalkori or at least one ALK inhibitor therapy.

On April 3, Pfizer issued a press release announcing the grant of a marketing authorization by the European Medicines Agency for Vizimpro in first-line EGFR-mutated NSCLC indications.

On February 11, Pfizer issued a press release announcing the FDA’s acceptance of its application seeking approval for a Bavencio and Inlyta combination regimen in first-line advanced RCC (renal cell carcinoma) indications. On March 8, Pfizer issued a press release announcing the validation—and, thereafter, the commencement—of the review of an application seeking approval for a Bavencio and Inlyta combination regimen in advanced first-line RCC indications. These applications are based on the results from the Phase 3 JAVELIN RENAL 101 trial, in which a Bavencio and Inlyta combination regimen proved to be superior in progression-free survival to Sutent in advanced first-line RCC indications.

On November 21, Pfizer issued a press release announcing the FDA’s approval of Daurismo in first-line acute myeloid leukemia indications in which patients aren’t eligible for chemotherapy.

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