Pfizer Shows Positive Results For Palbociclib Plus Letrozole For Breast Cancer
By Cyndi Root
Pfizer Inc. announced in a press release that palbociclib and letrozole in combination performed better than letrozole alone. The Phase II trial [PALOMA-1] met the primary endpoint of improving progression-free survival (PFS) for women with breast cancer. The statistical improvement was seen in women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), local or metastatic breast cancer. The study was conducted with Jonsson Cancer Center’s Revlon/UCLA Women’s Cancer Research Program and over 100 study sites globally. Pfizer plans to conduct Phase III studies.
Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology said, “We are delighted with the final data, which suggest the potential for palbociclib to transform the standard of care for post-menopausal women with ER+ and HER2- advanced breast cancer.” He added that this treatment could benefit 60% of women with breast cancer. He said Pfizer plans to review the results with the Food and Drug Administration (FDA) and plan the next steps.
Breast Cancer
Breast cancer is malignant cells that proliferate in the breasts. The cancer may stay local or metastasize and spread to other parts of the body. Common types are ductal carcinoma and lobular carcinoma. Men and women can get breast cancer, but it mostly occurs in women, with rare cases in men. New female cases number over 200,000 per year with about 40,000 women dying each year.
Palbociclib
Palbociclib is an investigational drug, not approved, but the FDA gave palbociclib a Breakthrough Therapy Designation. Palbociclib controls the cell cycle by inhibiting cyclin-dependent kinases (CDKs) 4 and 6, thereby stopping or slowing tumor cells from multiplying. Control of the cell is a breakthrough, as cancer cells are overactive by nature. Phase III studies of palbociclib are planned. PALOMA-2 (Study 1008) will evaluate palbociclib in combination with letrozole. PALOMA-3 (Study 1023) will study palbociclib in combination with fulvestrant. PENELOPE-B is a Phase 3 study of palbociclib with endocrine therapy.
About Pfizer
Pfizer company headquarters are in New York, NY. A globally positioned firm, Pfizer has numerous pharmaceutical products. Well known drugs include Lipitor, Zoloft, and Viagra. It also has some drugs for rare diseases like Elelyso and
Vyndaqel. Its portfolio includes molecules, vaccines, and biologics.
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