Pfizer Reveals Positive Results Of Phase 3 PALOMA-2 Clinical Trial Of IBRANCE

Pfizer Inc PFE revealed positive top line results from its stage three PALOMA-2 study for IBRANCE, which is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. The company disclosed that the trial met its primary endpoint by showcasing an enhancement in progression-free survival for the combination of IBRANCE plus letrozole versus letrozole plus placebo in post-menopausal women with estrogen receptor-positive.

Pfizer said its PALOMA-2 study offered confirmatory proof for IBRANCE in alliance with letrozole in the first-line setting that was first studied in the stage two of the study. The company said these data would support more planned regulatory submissions at the global level and provided an opportunity to seek the conversion of the accelerated approval in the America.

The company's Chief Medical Officer of Oncology & SVP Global Product Development, Mace Rothenberg, said "PALOMA-2 represents the third randomized study to demonstrate the benefit of IBRANCE when added to hormonal therapy in the management of women with ER+, HER2- advanced breast cancer. IBRANCE remains the only CDK 4/6 inhibitor with Phase 3 data in this disease. These results provide confirmatory evidence for PALOMA-1 and will be used to support regulatory submissions around the world, including a request for conversion of IBRANCE from accelerated to full approval in the United States. We look forward to sharing the detailed results of PALOMA-2 with the oncology community and advancing our discussions with regulatory authorities."

The Pharmaceutical firm said that since its introduction in February 2015, over 25,000 women were prescribed IBRANCE by over 6,000 prescribers in the U.S.

Pfizer's statement said "Based on the results of PALOMA-1, IBRANCE first was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for the treatment of postmenopausal women with ER+, HER2- advanced breast cancer in combination with letrozole as initial endocrine-based therapy for their metastatic disease.1 The indication in combination with letrozole was approved under accelerated approval based on PFS."

According to the press statement, "As stated at the time of the approval, continued approval for this indication may be contingent upon verification and description of clinical benefit in PALOMA-2, which the FDA identified as the confirmatory trial.1 Pfizer will work with the FDA to submit the results of PALOMA-2 to support conversion of the accelerated approval for IBRANCE to regular approval in the U.S."