Federal health regulators have provided an early approval to Pfizer Inc.’s Breakthrough breast cancer drug palbociclib.
The company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Ibrance (palbociclib) in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The agency’s approval came more than two months earlier than expected.
Accelerated approval was based on progression-free survival (PFS) results. Accelerated approval allows early market access for Ibrance. However, Pfizer will have to conduct additional clinical trials to confirm its efficacy in patients with advanced breast cancer.
Ibrance is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, which are key regulators of the cell cycle that trigger cellular progression. It was granted Breakthrough Therapy Designation and Priority Review from the FDA.
“The approval of Ibrance demonstrates how the strength of Pfizer’s innovative core and strong partnerships with academia can combine to translate novel science into meaningful new medicines. We now have the first-line treatment option that has demonstrated substantial improvement over letrozole alone in postmenopausal women with ER+/HER2- metastatic breast cancer,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Ibrance represents an important scientific advance, as well as the first medicine in a new class of anti-cancer agents, CDK 4/6 inhibitors, to be approved by the FDA.”
J.P. Morgan estimated that the drug could generate annual sales of $4 billion by 2020. Approval of Ibrance gives Pfizer a first major success as it starts a new era in cancer drugs.
The drug’s approval was based on data from a study involving 165 postmenopausal women with ER+/HER2- metastatic breast cancer who had not received previous treatment for the advanced disease. In the study, the drug stopped tumors from growing for a median of more than 20 months, nearly twice as long as the current treatment alone.
“I am proud of the clinical program for Ibrance, which was discovered in Pfizer laboratories, and the innovation we are able to bring forward to the breast cancer community today. The registration trial showed that, compared to letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer, Ibrance in combination with letrozole almost doubled the time before tumor progression, delaying the need for later-line therapies including other hormonal agents and chemotherapies,” said Ian Read, chairman and CEO, Pfizer. “Today’s FDA approval of Ibrance marks a pivotal milestone that demonstrates the strength of our science, provides and important medicine to patients in need, and underscores the contributions our Company can make to society.”
Source: Pfizer Inc.