Fulvestrant

An overall response rate of 82% was seen in relapsed or refractory follicular lymphoma patients treated with the asset. Credit: Lightspring / Shutterstock. AbbVie has announced accelerated approval from the US Food and Drug Administration (FDA) for EPKINLY (epcoritamab-bysp) to treat adult patients with relapsed or refractory follicular lymphoma  (R/R FL). A T-cell engaging bispecific antibody for subcutaneous administration, EPKINLY is indicated for R/R FL patients following treatment with two or more lines of previous therapy. The approval is based on the overall response rate and response durability elicited by the trial asset. Continued approval will follow on the regulator validating the clinical benefit of the antibody in a confirmatory trial(s). Developed jointly by AbbVie and Genmab in a oncology partnership, epcoritamab will be commercialised by the parties in the US and Japan. AbbVie will manage global commercialisation of the asset. See Also: AstraZeneca’s Tagrisso receives approval in Japan for lung cancer AstraZeneca’s Truqap and Faslodex combo receives approval in EU The FDA’s decision is based on the Phase I/II EPCORE NHL-1 clinical trial, which assessed EPKINLY’s safety and efficacy in 127 patients with a median of three previous therapies, 70% of whom had double refractory disease. According to the findings, an overall % response rate of 82% was seen in subjects treated with EPKINLY, the trial’s primary endpoint. 60% experienced a complete response while 22% had a partial response. At a median 14.8-month follow-up, the median duration of response had not been reached while sustained efficacy was observed in more than half of the responding patients. Injection site reactions, cytokine release syndrome and Covid-19 were among the most common adverse reactions reported in the trial. AbbVie haematology therapeutic area head and vice-president Mariana Cota Stirner stated: “EPKINLY treatment has shown deep and durable responses for many patients. Subcutaneous dosing offers convenience, and EPKINLY can be given to patients without mandatory hospitalisation using a three-step-up dosing regimen. “We believe that EPKINLY has the potential to be a core therapy in the treatment of multiple B-cell malignancies and furthers our company mission to advance research to raise standards of care for patients with cancer.” The latest development comes after the US FDA issued a complete response letter for the new drug application of AbbVie’s ABBV-951 to treat motor fluctuations in adult patients with advanced Parkinson’s disease.

Participants with unresectable or metastatic solid tumours that overexpress HER2 will be part of the Phase I trial. Credit: Vink Fan via Shutterstock. The US Food and Drug Administration (FDA) has granted Fast Track designation for Carisma Therapeutics ’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2). An ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy, CT-0525 is being analysed in a Phase I clinical trial. The open-label trial is designed to assess the safety, tolerability, and manufacturing feasibility of the therapy. Participants enrolled in the trial will include those with locally advanced (unresectable) or metastatic solid tumours that overexpress HER2 and have advanced following treatment with standard therapies approved presently. The trial will also feature two dose escalation cohorts to determine the optimal dose of CT-0525. See Also: AstraZeneca’s Tagrisso receives approval in Japan for lung cancer AstraZeneca’s Truqap and Faslodex combo receives approval in EU With the receipt of FDA Fast Track status, CT-0525 is now poised for an accelerated review process. Carisma Therapeutics CMO Eugene Kennedy said: “Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA’s recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need. “We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase I clinical trial and remain on track to report initial clinical data by the end of 2024.” This designation is a significant milestone, intended to expedite the development and review of therapies for serious conditions with unmet medical needs. In 2022, Carisma Therapeutics and Sesen Bio signed a definitive merger agreement to combine businesses and create a clinical-stage biotechnology company in an all-stock deal. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy