Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Pfizer’s supplemental New Drug Application (sNDA) for IBRANCE was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.”


Video: Dr. Saeed Rafii on the Phase Ib JAVELIN Trial Examining Avelumab in Breast Cancer

“Saeed Rafii, MD, PhD, MRCP, medical oncologist, medical director, Sarah Cannon Research Institute, London, discusses the phase Ib JAVELIN solid tumor trial. The trial looks at the anti-PD-L1 antibody avelumab (MSB0010718C) in patients with locally advanced or metastatic breast cancer. Rafii said the trial looked at 168 patients, regardless of the subtype of their breast cancer.

“Patients enrolled in the trial must have had 3 or fewer lines of chemotherapy prior to receieving avelumab. Rafii said of the patients, 10% experiences immune-related events. He also added that 8 patients had to stop due to treatment-related toxicities and that there were 2 mortalities. One of the 2 mortalities were from acute hepatic failure and another from respitority distress.”

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Video: Dr. Joanne Blum on the Function of Talazoparib in Locally Advanced and/or Metastatic Breast Cancer

“Joanne Blum, MD, PhD, breast medical oncologist, director, Hereditary Cancer Risk Program, Baylor Charles A. Sammons Cancer Center, discusses the function of the oral PARP inhibitor talazoparib (BMN 673) in BRCA mutation subjects with locally advanced and/or metastatic breast cancer. Blum says the BRCA mutation works in combination with talazoparib in order to better cut off the appropriate pathways for the tumors.

“Blum said during the phase I trial that looked at talazoparib, patients experienced grade 1 neutropenia, cytopenia and fatigue. Blum added that the toxicities were very mild.”

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Resistance Mutations: Next in ER+ Metastatic Breast Cancer?

“Estrogen receptor (ER) mutations can be easily detected in the plasma of patients with metastatic breast cancer and may hold the key to targeted treatments for women with endocrine-resistant disease, according to new analysis of patients in the BOLERO-2 trial.

” ‘Patients who had mutations had a shorter median survival than those who did not…and patients with different mutations might have different responses to therapies,’ Sarat Chandarlapaty, MD, PhD, a breast medical oncologist from Memorial Sloan Kettering Cancer Center in New York reported at the San Antonio Breast Cancer Symposium.

“BOLERO-2 enrolled postmenopausal women with metastatic, endocrine-resistant, ER-positive breast cancer and changed the standard of care in this setting, as reported by Medscape Medical News.”


Atezolizumab/Nab-Paclitaxel Combo Shows High Response Rates in TNBC

“Upfront treatment with the PD-L1 inhibitor atezolizumab (MPDL3280A) plus nab-paclitaxel (Abraxane) showed a confirmed objective response rate (ORR) of 66.7% in patients with metastatic triple-negative breast cancer (TNBC), according to data presented at the 2015 San Antonio Breast Cancer Symposium.

“In the phase Ib study, atezolizumab plus nab-paclitaxel was explored across several lines of treatment regardless of PD-L1 status for patients with metastatic TNBC. In the second-line setting, the confirmed ORR was 25% and in the third-line and beyond the ORR was 28.6%. Across the full trial, the ORR was 41.7%.

“ ‘For the efficacy, we saw a very high response rate, which is extremely exciting and encouraging,’ said lead investigator Sylvia Adams, MD, associate professor of Medicine, NYU Perlmutter Cancer Center. ‘The combination was well-tolerated without additive toxicity. We saw only toxicity that was predictable for the single agents alone.’ “


Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”


T-DM1 Improved Overall Survival for Heavily Pretreated Patients With HER2-positive Breast Cancer

“Among patients with HER2-positive, metastatic breast cancer that had progressed despite treatment with two or more forms of HER2-targeted therapy (trastuzumab [Herceptin] and lapatinib [Tykerb]), median overall survival was increased for those treated with trastuzumab emtansine (T-DM1 [Kadcyla]) compared with those who received treatment of physician’s choice, according to results from the phase III TH3RESA clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“The HER2-targeted antibody-drug conjugate T-DM1 was approved by the U.S. Food and Drug Administration in February 2013 for treating patients with HER2-positive, metastatic breast cancer that had progressed after treatment with trastuzumab and a taxane.”


FDA Grants Priority Review to Ibrance for New Indication in Advanced Breast Cancer

“The FDA granted priority review to a supplemental new drug application for the breast cancer medication palbociclib.

“Palbociclib (Ibrance, Pfizer) — an oral agent that inhibits cyclin-dependent kinases (CDK) 4 and 6 — already is approved for use in combination with letrozole for treatment of postmenopausal women with ER-positive, HER-2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.

“The supplemental application requests that the approval be expanded to allow for use of palbociclib in combination with fulvestrant in women with hormone receptor-positive, HER-2–negative metastatic breast cancer that progressed after endocrine therapy. The application requests approval in this setting regardless of patients’ menopausal status or receipt of prior treatment for metastatic disease.”


Dual HER2 Blockade Fails to Improve Response Rate in HER2-Positive Breast Cancer

“Dual HER2 blockade with trastuzumab and lapatinib was no better than trastuzumab alone in producing pathologic complete responses (pCR) in metastatic HER2-positive breast cancer patients in the neoadjuvant setting, according to a new study. Those with hormone receptor–negative disease did see an improvement with the dual blockade.

“ ‘In randomized neoadjuvant trials, dual HER2 targeting generally results in higher pCR rates, but the magnitude of this effect has varied,’ wrote study authors led by Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill. The new trial was a three-arm study of preoperative therapy in 305 patients with stage II/III HER2-positive breast cancer; 118 patients were randomized to paclitaxel along with trastuzumab and lapatinib, 120 to paclitaxel with trastuzumab alone, and another 67 to paclitaxel along with only lapatinib. That last trial arm was closed early. Results were published online ahead of print in the Journal of Clinical Oncology.”