Pfizer breast cancer pill gets FDA nod
pharmafile | October 14, 2014 | News story | Research and Development, Sales and Marketing | FDA, Femera, LEE011, Pfizer, bemaciclib, breast cancer, palbociclib
Pfizer’s experimental breast cancer drug palbociclib has been accepted and granted a priority review by the US Food and Drug Administration which can speed its approval process by up to four months.
The firm submitted an early application for its drug in August that is used to treat postmenopausal women with advanced breast cancer, in combination with the FDA-approved treatment Femara (letrozole) from Novartis.
The new drug is being heralded as a potential blockbuster, with some analysts predicting peak annual sales of around $3-5 billion, according to Reuters.
“If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the US who are living with metastatic breast cancer,” says Garry Nicholson, president, Pfizer Oncology.
The FDA gives priority review status to drugs that provide a treatment where no adequate therapy exists, and the status will expedite review time for palbociclib from 10 months to a goal of six months, with an FDA decision expected on the drug by April, Pfizer says in a statement.
Palbociclib received Breakthrough Therapy designation from the FDA in April last year, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.
It is an investigational agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control, and essentially block tumours from multiplying.
If approved it will lead an incoming pack of CDK 4/6 inhibitors that have the ability to make a significant difference for breast cancer patients, followed by Novartis’ LEE011, and Eli Lilly’s bemaciclib among others.
Pfizer has a lot riding on this treatment and also the head start on LEE011 which should be ready in 2016, and bemaciclib that could file in 2017.
Its PALOMA-1 Phase II study tested palbociclib in combination with the hormone therapy Femera and helped double survival rates in certain patients. It achieved its primary endpoint by significantly prolonging progression-free survival compared with Femera alone in post-menopausal women.
Results for the secondary endpoints of duration of treatment and clinical benefit rate also showed superiority in the palbociclib plus Femera arm, compared to the Femera-only arm.
Phoenix from the flames
The revival of this drug will be most pleasing to Pfizer as its course was largely abandoned in the 1990s after it failed to show consistent response against a broad range of cancers.
Since then the understanding of cancer – and notably its genetic roots – has given drugmakers new information on how these drugs, called CDK inhibitors, keep tumours from growing and metastasising.
Oncology has been a key growth area for the Pfizer since it started to lose patents on its record-breaking blockbuster Lipitor (atorvastatin) back in 2011.
Treatments such as its Xalkori (crizotinib) for lung cancer, Inlyta (axitinib) for renal cell carcinoma and Bosulif (bosutinib) for leukaemia have all received regulatory approval in the last number of years.
The firm will be very pleased with this latest fast review for palbociclib, and Nicholson adds: “We look forward to continuing to work closely with the FDA through the review process.”
Brett Wells
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