FDA approval for novel breast cancer drug granted ahead of anticipated target date
the ONA take:
The US Food and Drug Administration granted accelerated approved for palbociclib (Ibrance) for the treatment of advanced breast cancer in postmenopausal women whose tumors do not express HER2 protein.
Palbociclib blocks molecules linked to cancer cell growth; it is intended for use in combination with letrozole. Designated as a breakthrough drug in 2014, approval was granted 2 months ahead of its April 13 target date. A 165-patient study showed that palbociclib slowed the progression of breast cancer.
Patients taking palbociclib and letrozole lived 20.2 months on average before their tumors worsened. The most common side effects reported were low white blood cell count, fatigue, nausea, hair loss, diarrhea, vomiting, and nerve damage. The drug is manufactured by Pfizer Inc.
The FDA granted accelerated approved for palbociclib (Ibrance) for the treatment of advanced breast cancer.
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