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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FDA Approves Xermelo for Carcinoid Syndrome Diarrhea in Patients with Metastatic Neuroendocrine Tumors

Excerpt:

“The FDA approved telotristat ethyl tablets for use in combination with somatostatin analog therapy for the treatment of adults with carcinoid syndrome diarrhea.

“The approval is intended for patients with carcinoid syndrome — a rare and debilitating condition that affects people with carcinoid tumors and metastatic neuroendocrine tumors — that somatostatin analog therapy alone inadequately controlled. Carcinoid syndrome occurs in less than 10% of patients with carcinoid tumors. The tumors cause the excess release of the hormone serotonin, resulting in diarrhea, which in turn can lead to weight loss, malnutrition, dehydration and electrolyte imbalance.”

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Bristol Won’t Seek Faster Opdivo/Yervoy Lung Cancer Approval

Excerpt:

“Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.

“Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours.

“The pharmaceutical company cited ‘a review of data available at this time’ for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy.”

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Merck Wins Early U.S. Approval for Keytruda in Untreated Lung Cancer

Excerpt:

Merck & Co has won U.S. approval to market its immunotherapy Keytruda for use in previously untreated lung cancer patients two months ahead of schedule, making it the only such drug cleared for first-line treatment.

“The green light from the Food and Drug Administration (FDA), announced by the U.S. drugmaker late on Monday, confirms Merck’s leading position in the hot area of medicines that fight tumors by harnessing the body’s immune system.

“Keytruda’s latest approval is for treating first-line metastatic non-small cell lung cancer (NSCLC) in patients with high-levels of a protein called PD-L1, which makes them more receptive to immunotherapy.”

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War of the Checkpoint Inhibitors: Anti-PD-1 Drugs Move into First-Line Treatment in NSCLC


Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their drugs. To this end, they have conducted clinical trials testing each as a first-line treatment (i.e., in previously untreated patients), comparing them to standard chemotherapy. Continue reading…


FDA Approves Atezolizumab for Lung Cancer

Excerpt:

“The FDA has approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring EGFR or ALK abnormalities.

“The approval is based on multiple clinical trials, the largest being the phase III OAK trial, which was presented at the 2016 ESMO Congress. In the study, atezolizumab reduced the risk of death by 26% compared with docetaxel in patients with advanced NSCLC following the failure of platinum-based chemotherapy. The median overall survival (OS) was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy. The survival benefit with atezolizumab was observed regardless of PD-L1 status or histology.”

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FDA Approves Axumin to Detect Recurrent Prostate Cancer

Excerpt:

“The FDA today approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer.

“The agent is indicated for PET imaging in men who have suspected prostate cancer recurrence based on elevated PSA levels following treatment.

“The FDA based its decision on results of two studies that evaluated the safety and efficacy of Axumin (Blue Earth Diagnostics). One study compared 105 Axumin scans to histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in men suspected of having prostate cancer recurrence. In the second study, researchers evaluated 96 Axumin scans with C11 choline scans in patients with a median PSA of 1.44 ng/mL.”

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NSCLC Drug Hits Speed Bump on Road to FDA Approval

Excerpt:

“The FDA should wait for results of an ongoing phase III clinical trial before deciding whether to approve the EGFR inhibitor rociletinib for non-small cell lung cancer (NSCLC), advisers recommended today.

“The Oncologic Drugs Advisory Committee (ODAC) voted 12-1 in favor of the delay, although several committee members acknowledged that the drug demonstrated activity in two phase II trials submitted in support of the application for accelerated approval. Others, however, expressed a desire to see more compelling efficacy data from the larger, phase III trial, and some expressed uncertainty about about how to interpret the drug’s safety, specifically a 33% incidence of QT-prolongation in the single-arm phase II trials.

“Additionally, FDA staff review of the trial data ‘revealed high variability of systemic exposure to rociletinib and its major metabolites. Rociletinib demonstrated nonlinear pharmacokinetics, as systemic exposures did not increase when the dose increased from 500 mg to 1000 mg.’ ”

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