Tecoland supplies Palbociclib bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Palbociclib is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.
Palbociclib (trade name Ibrance) is a drug for the treatment of ER-positive and HER2-negative breast cancer developed by Pfizer. It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6.
The drug received an accelerated approval from the Food and Drug Administration on February 3, 2015, as a treatment (in combination with letrozole) for patients with estrogen receptor-positive advanced breast cancer. A potentially confirmatory phase 3 trial, PALOMA-2, has fully enrolled patients. The PALOMA-3 trial announced in April 2015 that the addition of palbociclib was superior to fulvestrant alone for progression-free survival.
In the phase 2 PALOMA-1 trial reported at the April 2014 annual meeting of the American Association for Cancer Research, the addition of palbociclib to letrozole was shown to significantly slow the progression of advanced cancer (median progression-free survival increased from 10.2 months to 20.2 months), but was not shown to have a statistically significant effect on increasing patients’ overall survival times.
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