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Nuventra Client G1 Therapeutics Receives FDA Approval for COSELA™

Nuventra is pleased to congratulate its client, G1 Therapeutics, on the approval of COSELA™ (trilaciclib). The drug is the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. COSELA™ received FDA Priority Review and Breakthrough Therapy designations for small cell lung cancer.

On behalf of our team at Nuventra, I want to congratulate everyone at G1 Therapeutics on this achievement,” says Geoffrey Banks, Ph.D., Nuventra’s CEO. “It’s always exciting to have contributed to an approved drug, particularly one such as trilaciclib that is going to impact patients in such a positive way. At the end of the day, this is what Nuventra is about with our mission to bring new medicines to patients by being the strategic provider of clinical pharmacology science and services.”

Nuventra’s team of consultants have worked with G1 Therapeutics on the trilaciclib program since 2014. As the PK resource for the G1 team, Nuventra conducted the initial pharmacokinetic analyses of the first doses administered to healthy volunteers. We then continued to support the program as it continued into repeat dose studies in subjects and then in Phase 2 studies in patients. The Nuventra team also participated in authoring regulatory documents including the IND and co-authoring a peer-reviewed scientific publication. In addition, Nuventra provided population PK modeling and used allometric scaling simulations to determine the appropriate First-in-Human dose used in the clinical trials.

Bill Wargin, Nuventra’s Co-Founder, said, “I very much enjoyed working with the scientists at G1 Therapeutics during the development of their CDK4/6 inhibitor COSELA™. As a supporting Pharmacokineticist, I was viewed as a member of their project team and was fortunate to be able to be involved at a very early stage in development. This opportunity to be an active participant on a project team as a consultant, and to see that project result in a drug that is safe and effective for the treatment of cancer, is one of the most exciting events in my professional career.”

Nuventra continues to work with G1 Therapeutics on other products in their pipeline.

About G1 Therapeutics

G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. 

About Nuventra

Nuventra is the pharmaceutical industry’s go-to resource for clinical pharmacology, pharmacokinetic, and pharmacometric consulting services. Nuventra gives pharmaceutical companies and CROs rare access to a hands-on team of industry-leading consultants experienced in complex studies and analyses. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic and pharmacometric principals and making them understandable and usable for common sense drug development.