The week in industry: US FDA approves first FGFR kinase inhibitor

This week: Enesi Pharma (Abingdon, UK) enter into partnership to develop new vaccines against influenza, US FDA accept application from Norvatis (Basel, Switzerland) to expedite review of drug to treat wet age-related macular degeneration and Phase I/IB trial initiated for patients with advanced cancer.

Thumb untitled design
Apr 18, 2019
0
0

This week's industry news: 

US FDA approves first FGFR kinase inhibitor
Partnership to develop new vaccines against influenza
Biologics License Application from Novartis accepted by FDA
Phase I/IB trial initiated for patients with advanced cancer


US FDA approves first FGFR kinase inhibitor

Based in results from a Phase II clinical trial, Janssen Pharmaceuticals (Beerse, Belgium) have received accelerated approval from the US FDA for BALVERSA™ (erdaftinib). Balversa is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUS) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

"I've spent my career specializing in the care of patients with metastatic urothelial carcinoma and understand the need for new treatments for this disease," commented Arlene O. Siefker-Radtke, Professor of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center (TX, USA), and lead study investigator. "BALVERSA is an important new therapy for this small subset of patients with urothelial carcinoma who, up until now, had limited treatment options."

Read more


Back to top of page

Partnership to develop new vaccines against influenza

Enesi Pharma (Abingdon, UK) and the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation and Ventures) have entered into a public-private partnership to advance the development of novel vaccines against influenza. The partnership will make use of Enesi’s ImplaVax®, a novel formulation and needle-free device technology that enables solid dose vaccine implants to be delivered quickly under the skin.

David Hipkiss, CEO, Enesi, commented, “We are extremely proud to have been selected by BARDA DRIVe for this partnership. The team at DRIVe has been incredibly supportive of Enesi and clearly recognize the need to revolutionize vaccine delivery as part of their mission to advance research and development of medical countermeasures against serious health security threats. This is the latest in a series of key strategic partnerships and represents the next step in our journey to make a tangible difference to global healthcare.”

Read more


Back to top of page

Biologics License Application from Novartis accepted by FDA

A Biologics License Application from Novartis (Basel, Switzerland) for brolucizumab (RTH258), to treat wet age-related macular degeneration (AMD), has been accepted by the US FDA. Using a priority review voucher, the company filled the application based on results from their Phase III trial data. They anticipate they will be able to launch the drug by the end of 2019.

“Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers," commented Fabrice Chouraqui, President of Novartis. "We are looking forward to the potential of a new option for patients with wet AMD, who often have to navigate considerable physical and emotional difficulties caused by deteriorating vision."

Read more


Back to top of page

Phase I/IB trial initiated for patients with advanced cancer

iTeos Therapeutics (Charleroi, Belgium) has enrolled its first cohort of patients for their Phase I/IB trial, studying their lead program candidate and investigational receptor antagonist – EOS100850. The key objectives of this open-label, dose-escalation study include understanding the safety and tolerability of the compound and determining a recommended Phase I dose.

“I am tremendously excited to announce that patient dosing in our innovative, adaptive Phase I/IB trial is now underway with EOS100850, our unique and specific A2A receptor antagonist. We believe we have a potential best-in-class compound, which was carefully designed with differentiating features to maximize the therapeutic window,” commented Michel Detheux, Co-Founder, President and Chief Executive Officer of iTeos.“

Read more


Back to top of page

Find more industry news here

Medium untitled design

RxNet

A network for the drug discovery and development community, Future Science Group

Your source for the latest news and views from the fields of drug discovery and medicinal chemistry.

No comments yet.