The U.S. Food and Drug Administration (FDA) has agreed to review a supplemental New Drug Application (sNDA) of CDK 4/6 inhibitor, IBRANCE (palbociclib) from Pfizer Inc. (NYSE:PFE). The sNDA was granted Priority Review status with an accelerated timeline of six months instead of the initial 10 months. Under the guidance of the Prescription Drug User Fee Act (PDUFA) the FDA’s date for a decision will be April 2017.
The sNDA supports the adaptation of the hastened approval of IBRANCE, which is an initial therapy for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. It is in combination with letrozole and has the inclusion of data from the Phase 3 PALOMA-2 trial.
Results from PALOMA-2, a randomized (2:1) double-blind Phase III study
The study sampled a total of 666 women from 186 sites in 17 countries. It was meant to demonstrate how IBRANCE in combination with letrozole improved progression-free survival in comparison to letrozole plus placebo. However, with IBRANCE in combination with letrozole in PALOMA-2, the adverse events observed proved to have a general consistency with their individual known and unfavorable event profiles.
The results, which were presented at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting in June, were encouraging according to the global president and general manager, Pfizer Oncology, Liz Barrett. She stated, “We are pleased that the PALOMA-2 trial has further demonstrated the significant clinical benefit of IBRANCE in the first-line setting, providing additional evidence for its continued use as a standard of care medicine.”
About IBRANCE the only FDA approved oral inhibitor of CDKs 4 and 6, 2
Having been introduced in 2015, more than 45,000 patients have received an IBRANCE prescription from more than 9,000 providers in the U.S. Besides, it is approved in more than 50 countries. Apart from been effective for postmenopausal women it can also be used in women with disease progression following endocrine therapy.2
However, the indication must be used under the clinical guidance and before its use, monitoring of complete blood count is strongly recommended at the beginning of each cycle. There is also an approval of dose reduction or delay particularly in patients who develop Grade 3 or 4 neutropenia. Meanwhile, Pfizer’s stock closed at $32.40 a decrease of $0.46 or 1.40%