Pfizer to submit breast cancer drug
pharmafile | May 18, 2014 | News story | Research and Development, Sales and Marketing | Pfizer, breast cancer, femara, palbociclib
Pfizer, currently in the middle of trying to acquire AstraZeneca for $106 billion, says it will soon submit its new breast cancer drug for FDA scrutiny.
The treatment, known as palbociclib, is seeking a US licence as first-line systemic treatment of post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
Pfizer says in a statement that it expects to submit the new drug application (NDA) “early in the third quarter of this year”.
This decision was based on discussions with the FDA regarding the final results of PALOMA-1, a Phase II trial comparing palbociclib plus Novartis’ breast cancer drug Femara (letrozole), versus Femara alone.
Even though Pfizer has not begun the final stages of testing, the FDA has told the firm it can submit the drug under the regulator’s new ‘breakthrough designation’, which speeds up the approval process for potentially important new medicines.
Pfizer presented data from the trial at a cancer meeting last month that showed patients in the study who took Pfizer’s medicine plus Femera, went 20.2 months on average before their cancer began to worsen, compared with 10.2 months for those that received only for Novartis’ medicine.
Palbociclib is considered to be one of the most important medicines in Pfizer’s developmental pipeline, with some analysts predicting peak annual sales of $5 billion.
Oncology has been a key growth area for the Pfizer since it started to lose patents on its record-breaking blockbuster Lipitor (atorvastatin) in 2011.
Treatments such as 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.
Palbociclib is part of a class of drugs called cyclin-dependent kinase (CDK) inhibitors which function by blocking the multiplication of tumour cells. Other firms developing similar treatments include Lilly, Novartis and Bayer, with Lilly currently seen as the biggest competitor for Pfizer’s drug.
Breast cancer is the most common type of cancer among women and lead to more than half a million deaths globally in 2011, according to the World Health Organization.
Ben Adams
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