The Food and Drug Administration has given its second approval to a drug under a pilot program that allows it to start analyzing data from trials of drugs in oncology before manufacturers formally submit approval applications.
The agency said Friday that it had approved Merck’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) combined with pemetrexed and platinum chemotherapy for first-line metastatic, non-squamous non-small cell lung cancer patients whose tumors do not carry EGFR or ALK genomic tumor aberrations.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The approval was granted under the pilot program, called Real-Time Oncology Review, or RTOR, based on results of the Phase III KEYNOTE-189 study. The combination had originally received accelerated approval based on the Phase I/II KEYNOTE-021 study, with completion of the randomized, double-blind, placebo-controlled KEYNOTE-189 being a condition of full approval. Keytruda was originally approved in September 2014 for melanoma, and has since won approval for numerous other cancers.
Keytruda’s label expansion marks the second approval under the RTOR program. In July, the agency granted its first RTOR approval, to Novartis’ Kisqali (ribociclib) combined with an aromatase inhibitor for women with HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy, before for after menopause. The agency also approved the drug combined with AstraZeneca’s Faslodex (fulvestrant) for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer as an initial endocrine-based therapy or after the disease progressed on endocrine therapy. Kisqali’s first approval came in March 2017, for HR-positive and HER2 negative advanced or metastatic disease, but only in postmenopausal women.
In addition to RTOR, the FDA granted the label expansions to Kisqali under its new Assessment Aid template, which manufacturers can use to organize their regulatory submissions into a structured format the facilitate a more streamlined review process.
The FDA launched the RTOR program in June, with the goal of making reviews more efficient and giving patients access to drugs as early as possible while maintaining and improving review quality. Overall, the process is designed take about 20 weeks, starting when drugmakers have topline trial data and have locked their study databases, according to the FDA, after which they can apply for RTOR with the agency.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Criteria that submissions have to meet for RTOR submission include likelihood of demonstrating substantial improvements over available therapy; straightforward study designs; easily interpreted trial endpoints, such as overall survival in a randomized trial. Studies conducted entirely outside the US and supplemental materials with chemistry, manufacturing and control formulation changes or pharmacology and toxicology data are excluded.
Photo: Waldemarus, Getty Images
