Pfizer Inc. (PFE) received encouraging news with the FDA granting priority review status to the company’s New Drug Application (NDA) for its oncology candidate, palbociclib. Pfizer is looking to get palbociclib approved in combination with Novartis’ (NVS) Femara (letrozole) for the first-line treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
With the FDA granting priority review status, a response should be out within six months instead of the customary ten months of receiving the regulatory application. We note that the FDA grants priority review status to candidates which have the potential to bring significant improvements in the treatment or prevention of serious diseases when compared to currently available therapies or where the current treatment is not adequate. We note that the FDA had granted Breakthrough Therapy designation to palbociclib for this indication in Apr 2013.
With the palbociclib NDA being submitted in August this year, a response from the FDA regarding its approval status should be out by Apr 13, 2015. The NDA is based on final results from the phase II PALOMA-1 study.
Pfizer is currently conducting two phase III studies on palbociclib (PALOMA-2 and PALOMA-3) for the treatment of advanced or metastatic breast cancer. PALOMA-2 (Study 1008) is evaluating palbociclib in combination with Femara versus Femara plus placebo as a first-line treatment for post-menopausal patients with ER+, HER2- advanced breast cancer.
PALOMA-3 (Study 1023) is evaluating palbociclib plus AstraZeneca’s (AZN) Faslodex (fulvestrant) versus Faslodex plus placebo in women with hormone receptor-positive (HR+), HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy. Both studies have completed patient enrollment.
We are encouraged by palbociclib gaining priority review status. Considering the advanced breast cancer patient population, palbociclib could bring in multi-billion dollar sales for Pfizer once approved and launched.
Pfizer currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Ligand Pharmaceuticals Inc. (LGND) carrying a Zacks Rank #1 (Strong Buy).
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