Novartis Breast Cancer Drug Set to Take on Pfizer's Ibrance

Excerpt:

“A clinical trial testing an experimental breast cancer pill from Novartis has been stopped early because of good results, boosting the Swiss company’s efforts to build up its oncology business.

“The news puts Novartis on track to compete with a similar blockbuster product from Pfizer that is already on the market.

“Novartis said on Wednesday that testing of LEE011 in combination with letrozole in the late-stage study had been halted early after it met its goal of significantly extending the time patients lived without their disease progressing.

“LEE011, or ribociclib, belongs to the same drug class as Pfizer’s Ibrance. The Novartis product now looks set to be second to market in the category, ahead of Eli Lilly’s abemaciclib, according to Berenberg Bank analysts.”

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Possible Treatment on Horizon for Advanced KRAS-Mutant NSCLC

Excerpt:

“Promising early phase clinical trials have led to the initiation of the phase III JUNIPER trial, which is assessing abemaciclib (LY2835219) for patients with previously treated KRAS-mutant lung cancer, a traditionally hard to treat genetic subtype.

“JUNIPER is an open label phase III study currently recruiting patients with stage IV non–small cell lung cancer (NSCLC) with a detectable KRAS mutation who have progressed following treatment with platinum-based chemotherapy (NCT02152631). Patients will be randomized to receive either abemaciclib or erlotinib, both with best supportive care.

“ ‘KRAS mutations are common in patients with NSCLC, but there have been few clinical advances in our treatment for these patients,’ said investigator Jonathan W. Goldman, MD, of the Department of Medicine, Hematology/Oncology, member of the Signal Transduction and Therapeutics Program Area at UCLA’s Jonsson Comprehensive Cancer Center, who explored the drug in a phase I trial.”

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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

“Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.”