“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.”
“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.”
With a few exceptions, glioblastoma (GBM) remains largely incurable, and the U.S. Food and Drug Administration (FDA) has approved few treatments for the disease. Surgery (when feasible), radiation, and temozolomide are used in most patients. But even if a newly diagnosed tumor can be surgically excised, recurrences are too common.
In this blog post, I simply list some of the new treatments available in clinical trials for GBM and other high-grade brain tumors. Only drugs that have at least some preliminary results of activity are included, and the list is not meant to be fully comprehensive. The interested reader can judge for herself what might be of interest, keeping in mind that no single treatment is suitable or will work for all GBM patients. Continue reading…
“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.”
“The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.
“ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).
“ ‘With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,’ Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. ‘Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.’ ”
“The FDA has granted a priority review to ceritinib (Zykadia) as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor.
“The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival (PFS) benefit favoring ceritinib was 8.5 months (HR, 0.55; 95% CI, 0.42-0.73; P <.001).”
“In December 2016, the FDA informed Advanced Accelerator Applications that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
“The application was based on the phase III NETTER-1 trial, which randomized patients with advanced, progressive, somatostatin receptor-positive midgut NETS to receive either Lutathera (116 patients) plus best supportive care, including octreotide long-acting repeatable (LAR), or octreotide LAR alone (113 patients).”
“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.”
“The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
“The CRL, which follows a discipline review letter (DRL) issued in November, requests new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Lutathera.”