March 9, 2015
By Alex Keown, BioSpace.com Breaking News Staff
GROTON, Conn. – A team of 100 Pfizer Inc. scientists is celebrating federal approval of breast cancer drug Ibrance, which some analysts predict could earn $3 to $5 billion in revenue for the New York-based pharmaceutical giant.
Last month the U.S. Food and Drug Administration (FDA) approved Ibrance (palbociclib) to treat advanced (metastatic) breast cancer. Ibrance works by inhibiting molecules involved in promoting the growth of cancer cells. The drug is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy, according to the FDA.
Ibrance was approved to be used in combination with letrozole, another FDA-approved product manufactured by Novartis AG and sold under the name Femara, which is used to treat certain kinds of breast cancer in postmenopausal women.
Ibrance was approved under the FDA’s accelerated approval program, which allows “approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.”
During clinical trials patients were provided with Ibrance in combination with letrozole or letrozole alone. Participants treated with Ibrance plus letrozole lived about 20.2 months without their disease progressing compared to about 10.2 months seen in participants receiving only letrozole.
Breast cancer in women is the second most common type of cancer in the United States. The National Cancer Institute (NCI) estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.
It wasn’t until 2008 that Pfizer scientists thought to combine Ibrance with letrozole and target a specific type of breast cancer. The breakthrough came after several years of setbacks, according to an article in New London, Conn.-based The Day. In 2013 the FDA granted Ibrance breakthrough therapy designation base on trial evidence the drug provided a substantial improvement over available therapies, according to the FDA. The drug was given a priority review status with a review date set for next month, but the federal agency approved the drug prior to its two-year review mark.
Pfizer praised the work of its team of scientists who were able to bring Ibrance through trials and ultimately to market. In an interview with Pfizer spokeswoman Jennifer Kokell praised the Groton-based Pfizer team for compressing five years of work into less than three years. Scientists and researchers at Pfizer’s Groton lab site were challenged to successfully bring the drug through clinical trial as quickly as possible.
The Day reported Pfizer scientists said that required them to speed up the manufacturing of active ingredients, standardization of clinical supplies and optimization of technology involved in the drugmaking process. It also required coordinated efforts with other Pfizer manufacturing sites in the United Kingdom.
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?
