Pfizer’s Breast Cancer Pill Gets FDA Priority Review

Pfizer’s experimental breast cancer drug palbociclib has been accepted and granted a priority review by the FDA, this could lead to a quicker solution, speeding its approval process by up to four months.

Pfizer submitted its application for the drug back in August, when the company was involved in a controversial takeover attempt of AstraZeneca. The drug palbociclib can be used to treat postmenopausal women with advanced breast cancer and works in combination with the already approved treatment Femara from Novartis.

Labelled already as a potential blockbuster the new drug is being predicted by some analysts to have the potential to bring in between $3-5 billion in annual sales.

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 doesn’t hand these priority reviews out very easily and will only give priority reviews to drugs that provide a treatment where no adequate therapy pre exists. With palbociclib being given this status it will reduce review time from ten months to a goal of six months, with the FDA expecting to reveal their decision on the drug in April.

PALOMA-1 Phase II study tested palbociclib in combination with Novartis’s hormone therapy Femera and helped double the survival rates in certain patients. It then achieved its primary endpoint by significantly prolonging progresseion free survival when soley compared with Femera, 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.

The most pleasing news for Pfizer will the revival of the drug as it was abandoned during the the 90’s after it failed to show any consistency against a broad range of cancers. Since then though the understanding of cancer has had great advances especially in the knowledge of the roots of cancer. This has led to drugmakers using this information to create drugs called CDK inhibitors which 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.”

Alex Carson

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