Novartis Gets FDA Approval for Skin Cancer Drug Combination

“Nov 20 Novartis AG said on Friday it received the U.S. Food and Drug Administration’s regular approval for a drug combination to treat an aggressive form of skin cancer.

“The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years overall survival in patients, the company said.

“The combination was initially approved based on mid-stage data through the FDA’s accelerated approval program, but the approval was contingent on data from late-stage trial.”

UPDATE 1-Novartis Works with Bristol-Myers Squibb to Test Lung Cancer Drugs

The gist: Combining existing drugs can sometimes result in new, more effective cancer treatments. As we posted on our Need to Know blog today, lung cancer researchers are testing drug combinations that involve immunotherapies—treatments that boost the immune system to fight cancer. Now, two drug companies have announced that they will be testing combinations of their lung cancer drugs. An immunotherapy drug called Opdivo will be combined with targeted drugs. The combinations will be tested in clinical trials with volunteer patients who have late-stage non-small cell lung cancer (NSCLC). It is hoped that the combinations will work better than any of the drugs alone.

“Swiss pharma group Novartis AG said on Monday it would work with Bristol-Myers Squibb Co to test the U.S. drugmaker’s immuno-oncology drug Opdivo in combination with three of its own experimental lung cancer drugs.

“The clinical collaboration will help Novartis advance its efforts in the field of immunotherapy, one of the hottest areas in biotech right now, following the acquisition of CoStim Pharmaceuticals Inc this year, the drugmaker said.

“Novartis currently lags rivals such as Roche, Merck , AstraZeneca and Bristol-Myers in the race to develop immunotherapies – drugs that fight cancer by harnessing the body’s immune system.

“The two companies will test the combination of three molecularly targeted compounds with Bristol-Myers’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in phase I and II studies, Novartis said, adding it would conduct both studies.

” ‘Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients,’ Alessandro Riva, global head of Novartis oncology development and medical affairs, said in the statement.”

Growing Participation in Novartis' Signature Program Bodes Well for Novel PGx Signal Finding Approach

The gist: The Signature Program lets people with different kinds of cancer across the U.S. access new, promising drugs that are still in the testing phase (i.e. they cannot yet be simply prescribed by oncologists). The program matches patients to different treatments based on the distinct genetic changes found in each patient’s tumor. According to this article, Signature is enrolling an “encouraging” amount of patients. And, it may be driving more oncologists at community healthcare settings to use molecular testing to help patients choose their best treatment options. Learn more about Signature at our Need to Know blog.

“Participation in Novartis’ biomarker based signal-finding trials, known as the Signature Program, is progressing at an encouraging pace, according to researchers involved in the effort.

“Novartis last year launched the Signature Program, a drug trial series in which patients are enrolled into mutation-specific study protocols that are tissue agnostic. Currently, cancer drugs are studied and approved according to a specific tumor site or histology (ie. breast cancer, lung cancer, etc). However, with advances in genomic knowledge, life sciences experts have often discussed future scenarios where therapies will be studied in and approved for the specific molecular pathways they interrogate. Novartis is taking the first step toward exploring such a vision through the Signature Program.”

Novartis Revolutionizes Clinical Trials for Targeted Cancer Drugs

Someone had to do it; now it looks like Novartis may be the first. The pharma company’s new series of clinical trials, SIGNATURE (also known as, ‘bring the protocol to the patient,’ or  ‘P2P’), is recruiting patients with different cancers to receive investigational targeted drugs selected to match the distinct genetic changes found in each patient’s tumor. Continue reading…

FDA Fast-Tracks Approval Process for Lung Cancer Drug LDK378

The FDA has designated Novartis’s anti-cancer drug LDK378 as a breakthrough therapy, thereby placing it on a faster track for FDA approval. “Breakthrough therapy” is a status reserved for drugs that treat serious conditions and that have been shown in preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).

FDA seeks to fast track Novartis lung cancer drug

“The U.S. Food and Drug Administration has designated a compound developed by Novartis AG to treat a type of non-small cell lung cancer for fast-track development and review, the Swiss drugmaker said on Friday.”