FDA Grants Orphan Drug Designation to Tucatinib for Brain Metastases

Excerpt:

“The FDA granted orphan drug designation to tucatinib for the treatment of patients with breast cancer whose disease metastasized to the brain, according to the drug’s manufacturer.

“Tucatinib (ONT-380, Cascadian Therapeutics) is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER-2 without significant inhibition of EGFR, which has been associated with significant toxicities.”

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Dual HER2 Blockade Superior to Single Blockade for HER2+/HR+ Breast Cancer

Excerpt:

“Dual blockade of HER2 with lapatinib plus trastuzumab and an aromatase inhibitor (AI) was superior to single blockade with trastuzumab plus an AI in postmenopausal women with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer, according to the results of the phase III ALTERNATIVE study (abstract 1004) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.

” ‘Dual HER2 blockade with this triplet of lapatinib/trastuzumab and an AI can offer an effective and well-tolerated chemotherapy-sparing option for patients who are not intended or appropriate for chemotherapy,’ said researcher William J. Gradishar, MD, of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, who presented the results.”

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Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

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Longer Survival Seen with Breast Cancer Mets

Excerpt:

“An increasing number of women in the U.S. survive with metastatic breast cancer (MBC) as both median and 5-year survival rates improved, especially among younger women, according to a back-calculation method study.

“As of Jan. 1, 2017, 154,794 women were estimated to be living with MBC in the country, 75% of whom had initial diagnoses of stage I to III breast cancer and later progressed to MBC, reported Angela Mariotto, PhD, of the NCI in Bethesda, Md., and colleagues.

“The data showed a twofold increase in 5-year survival for women, ages 15 to 49, with MBC at diagnosis (de novo MBC), from 18% in 1992-1994 to 36% in 2005-2012, they wrote in Cancer Epidemiology, Biomarkers & Prevention.”

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FDA Approves Co-Packaging of Ribociclib With Letrozole for Metastatic Breast Cancer

Excerpt:

“The FDA has approved co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.

“With the new Kisqali Femara Co-Pack, patients can obtain a full 28-day cycle of the 2 medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.”

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FDA Grants Fast Track Designation to Reolysin for Metastatic Breast Cancer

Excerpt:

“The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.

“Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.

“An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.”

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CDK4/6 Agent Active in Metastatic Breast Cancer

Excerpt:

“About one in five patients with post-chemotherapy metastatic breast cancer attained an objective response to single-agent therapy with the cyclin-dependent kinase (CDK)4/6 inhibitor abemaciclib, results of a phase II trial showed.

“Responses were durable, lasting an average of almost 9 months, and more than 40% of patients obtained clinical benefit. Abemaciclib’s safety and tolerability were consistent with previous clinical experience, as no new or unexpected adverse events occurred among 132 patients who received the drug.”

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Ribociclib Response Unaffected by Prior Treatment

Excerpt:

“The FDA recently approved ribociclib (Kisqali) for use in combination with an aromatase inhibitor as initial therapy for treatment of postmenopausal women with HR+/HER2-negative advanced or metastatic breast cancer.

“Ribociclib, an inhibitor of CDK4/6, was approved based on data from the phase III MONALEESA-2 trial, which was ended early following the first preplanned interim analysis. In this analysis, the combination of ribociclib and the aromatase inhibitor letrozole met the trial’s primary endpoint by demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone.”

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Novartis Kisqali® (Ribociclib, LEE011) Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Cancer in Combination with Any Aromatase Inhibitor

Excerpt:

“The US Food and Drug Administration (FDA) has approved Kisqali®(ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

“Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.”

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