Fulvestrant Gains New Breast Cancer Indication


“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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Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686 for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer (NSCLC) in Patients with the T790M Mutation

Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation. The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M.”

Editor’s note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to first-line treatment and develop a new mutation called T790M. Evidence shows that non-small cell lung cancer (NSCLC) patients with T790M may benefit from second-line treatment with CO-1686.The drug has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This means that the FDA finds CO-1686 to be very promising compared to currently available treatments for T790M-mutated NSCLC, and will accelerate the approval process that would ultimately permit oncologists to prescribe the drug outside of a clinical trial.

Checkpoint Modulation in Melanoma: An Update on Ipilimumab and Future Directions

“Ipilimumab, an anti-cytotoxic T-lymphocyte antigen 4 antibody, was the first therapy demonstrated to improve overall survival in melanoma. Since ipilimumab’s approval by the FDA in 2011, a wealth of data has amassed, helping clinicians to optimize its use. We have learned how to mitigate the adverse effects of ipilimumab, identified its effects in melanoma subpopulations such as those with brain metastases, uveal melanoma, and mucosal melanoma, discovered potential biomarkers of activity, and investigated its use in combination with other therapeutic modalities. These discoveries have paved the way for rapid development of second-generation immunomodulatory antibodies such as inhibitors of the programmed cell death 1 receptor axis. These new agents hold promise as monotherapy, but perhaps the greatest allure lies in the possibility of combining these agents in synergistic multidrug regimens.”

ASCO: Enzalutamide Monotherapy in Prostate Cancer Achieves ‘High Response Rate, Marked PSA Decline'

“Monotherapy with enzalutamide (Xtandi) achieved a “high PSA response rate and marked PSA decline” in patients with hormone-naïve prostate cancer after 6 months in a single-arm, multicenter phase II study, reported Matthew Raymond Smith, MD, PhD, of the Massachusetts General Hospital Cancer Center, Boston (abstract 5001). Efficacy was similar to castration, but in contrast with castration, bone mineral density (BMD) remained stable and metabolic variables, including fat body mass, lipid, and glycemic profiles, were not substantially impacted by enzalutamide over the 6-month study period.”

Polytherapy Beats Monotherapy as Second-Line Treatment for NSCLC

Combining targeted therapy improves overall survival for patients with non-small cell lung cancer (NSCLC), compared to using the targeted drug erlotinib (Tarceva) alone, according to a recent study. By pooling data from eight clinical trials, researchers found that patient outcomes were improved when combination therapy was used as a second-line treatment for NSCLC.

Patients with advanced NSCLC who have already received initial therapy usually take erlotinib alone as a second-line treatment. Erlotinib directly targets the EGFR protein and can be particularly effective for patients with mutations in the EGFR gene. Continue reading…