Pharma giant Pfizer, Inc. (PFE) announced late Tuesday that the U.S. Food and Drug Administration or FDA, has granted accelerated approval of Ibrance (palbociclib), in combination with letrozole, as first-line systemic treatment for advanced or metastatic breast cancer in post-menopausal women.
This will be the first medicine in a new class of anti-cancer agents, cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors, to be approved by the FDA.
The FDA approved the breast cancer drug Ibrance more than two months ahead of the scheduled Prescription Drug User Fee Act (PDUFA) goal date of April 13, 2015.
"Today's FDA approval of IBRANCE marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need, and underscores the contributions our company can make to society," Chairman and CEO Ian Read said in a statement.
Pfizer submitted the New Drug Application or NDA, to the FDA in mid-August and it was granted Priority Review by the FDA on October 13, 2014. The drug received Breakthrough Therapy designation from the FDA in April 2013.
The FDA's Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
Ibrance is indicated as a first-line treatment for 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.
Pfizer said the indication is approved under accelerated approval based on progression-free survival or PFS. The Ibrance NDA was based on the final results of the Phase 2 PALOMA-1 trial.
The PALOMA-1 trial achieved its primary endpoint by demonstrating that Ibrance in combination with letrozole prolonged PFS compared with letrozole alone for the indication. It almost doubled the time before tumor progression, delaying the need for later-line therapies including other hormonal agents and chemotherapies.
The company noted that continued approval for the indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. It added that Ibrance is not currently approved for any indication in any market outside the U.S.
Pfizer announced that Ibrance is available to order immediately through select specialty pharmacies.
PFE closed Tuesday's regular trading session at $32.02, up $0.37 or 1.17% on a volume of 34.0 million shares. The stock gained a further $0.28 or 0.87% in after-hours trading.
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