Pfizer said Tuesday that the FDA granted accelerated approval to Ibrance (palbociclib), in combination with Novartis' Femara (letrozole), for the treatment of postmenopausal women with oestrogen receptor-positive, HER2-negative metastatic breast cancer. "We now have a first-line treatment option that has demonstrated substantial improvement over [Femara] alone," remarked Mace Rothenberg, chief medical officer for Pfizer Oncology, adding "Ibrance represents...the first medicine in a new class of anti-cancer agents, CDK 4/6 inhibitors, to be approved by the FDA."
Meanwhile, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "the FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations." The agency noted that Ibrance was approved more than two months ahead of the target review goal date of April 13.
Pfizer noted that approval of the therapy, which was also granted FDA breakthrough therapy status, was supported by data from the Phase II PALOMA-1 study, in which the combination of Ibrance and Femara was associated with a nearly two-fold improvement in progression-free survival (PFS) compared to treatment with Novartis' drug alone. Specifically, results showed that women treated with the combination therapy had a median PFS of 20.2 months compared to 10.2 months in women who received Femara alone. Pfizer said that a confirmatory Phase III trial, called PALOMA-2, is fully enrolled.
Last month, Pfizer indicated that it had been informed by the FDA that it did not plan to conduct an advisory committee meeting to review Ibrance and had entered label discussions with the regulator. For related analysis, see ViewPoints: All signs point to key breast cancer approval for Pfizer.
According to Pfizer, Ibrance will be priced at $9850 a month, or $118 200 per year. Analysts estimate that the product will generate annual sales of up to $4 billion by 2020.
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