FDA Grants Fast Track Designation to Elacestrant for Breast Cancer Subtype

Excerpt:

“The FDA granted fast track designation to elacestrant for the treatment of ER-positive, HER-2-negative advanced or metastatic breast cancer, according to the drug’s manufacturer.

“Elacestrant (RAD1901, Radius Health) an investigational oral selective ER downregulator/degrader is under investigation as a nonsteroidal treatment for hormone-driven or hormone-resistant breast cancer.”

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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

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FDA Approves Verzenio for Hormone Receptor-Positive, HER-2-Negative Breast Cancer

Excerpt:

“The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.”

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ESMO 2017 Press Release: LORELEI: Taselisib Boosts Breast Tumor Shrinkage

Excerpt:

“Adding taselisib to letrozole before surgery significantly improved outcomes for patients with early breast cancer that was both estrogen receptor positive and HER2-negative (ER+/HER2-) according to results of the LORELEI trial, presented at the ESMO 2017 Congress in Madrid.

” ‘We were able to detect a reduction in tumor size after only 16 weeks of treatment, compared to patients who received letrozole plus placebo,’ said study investigator Dr. Cristina Saura, from Vall d’Hebron University Hospital in Barcelona, Spain. ‘Any decrease in tumor measurements is something positive for patients because this means the drug has had activity against their tumor in a short period of time.’ ”

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Fulvestrant Gains New Breast Cancer Indication

Excerpt:

“The FDA expanded the indications for fulvestrant (Faslodex) to include use as first-line monotherapy in postmenopausal women with estrogen receptor-positive, HER-2 negative breast cancer, drugmaker AstraZeneca said Monday.

“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”

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ASCO 2017: I-SPY 2 Trial: Combination of Pembrolizumab Plus Standard Neoadjuvant Therapy in High-Risk Breast Cancer

Excerpt:

“At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer (Abstract 506).

“Findings showed that the addition of pembrolizumab increased the estimated pathologic complete response rate nearly threefold in patients with triple-negative breast cancer (60% vs 20%) and in patients with hormone receptor–positive/HER2-negative breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory phase III trial, pembrolizumab has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (triple-negative breast cancer, all HER2-negative, and hormone receptor–positive/HER2-negative).”

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Oral SERD Promising in ER-Positive Breast Cancer With ESR1 Mutations

Excerpt:

“The investigational third-generation nonsteroidal oral selective estrogen receptor degrader (SERD) RAD1901 was associated with a 23% objective response rate among 40 heavily pretreated women with estrogen receptor (ER)-positive, HER2-negative breast cancer, according to authors of a phase I dose-escalation and safety cohort study (NCT02338349) presented (abstract 1014) at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.”

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Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer

Excerpt:

“Eli Lilly and Company (NYSE: LLY) today announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively, HR: 0.553; 95% CI: 0.449, 0.681, P < .0000001). The data were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1000) and simultaneously published online in the Journal of Clinical Oncology.”

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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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