Cell therapy weekly: US FDA approves Novartis’ Kymriah® for follicular lymphoma in adults
This week: US FDA approves Novartis’ Kymriah® for follicular lymphoma in adults, Janssen gains approval for Carvykti® to treat relapsed and refractory multiple myeloma and Evotec to acquire Rigenerand in a bid to expand EVOcells platform for end-to-end cell therapy production.
The news highlights:
US FDA approves Novartis’ Kymriah® for follicular lymphoma in adults
Novartis (Basel, Switzerland) has announced that the US FDA has granted accelerated approval for Kymriah® (tisagenlecleucel). The approval will permit the treatment of adult patients with relapsed or refractory follicular lymphoma, a slow-growing blood cancer, after two or more lines of systemic therapy. The FDA’s decision comes after a review of the data from the Phase II ELARA trial, where 68% of the patients receiving Kymriah experienced a complete response, with an 86% overall response rate of the 90 examined patients. Kymriah is the only CAR-T therapy approved in both adult and pediatric settings, making it now FDA-approved in three indications.
“We are proud of today’s FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” commented Victor Bulto, President of Novartis Innovative Medicines US.
Janssen gains approval for Carvykti® to treat relapsed and refractory multiple myeloma
Janssen Pharmaceutical (NJ, USA) of Johnson & Johnson (NJ, USA) has announced it has been granted conditional approval for Carvykti® (Ciltacabtagene Autoleucel; cilta-cel) by the European Commission. The conditional marketing authorization will allow the use of Carvykti to treat adults with relapsed and refractory multiple myeloma. The CAR-T therapy will be conducted on patients that have received a minimum of three therapies and are still exhibiting disease progression, including an anti-CD38 antibody, an immunomodulatory agent and a proteasome inhibitor. Trial findings have shown that a single infusion of the treatment resulted in 98% of patients responding to the therapy at 18 months.
“Patients who have relapsed, or for whom treatment regimens have stopped working after experiencing the three major drug classes, typically face poor survival. Despite recent innovation, new therapeutic approaches are still needed,” commented Maria-Victoria Mateos, Consultant Physician in Haematology at the University Hospital of Salamanca (Spain). “A single infusion of cilta-cel resulted in durable responses in a heavily pre-treated patient population. These results support the potential of cilta-cel in offering patients and physicians a valuable new treatment option.”
Evotec to acquire Rigenerand in a bid to expand EVOcells platform for end-to-end cell therapy production
Evotec (Hamburg, Germany), a drug discovery and development company, will acquire Rigenerand (Medolla, Italy), a cell technology firm focused on the good manufacturing practice of cell therapies. The deal will see Evotec acquire 100% of Rigenerand’s capital for US$24.7m, including their 1200m² ‘cell factory’, a production facility merging cGMP manufacturing with research and development and quality control labs, as well as development labs. Evotec aims to make the facility part of the company’s EVOcells platform, an end-to-end process from cell therapy discovery to GMP manufacture. The company is currently searching for partners to aid in the development of projects.
“Cell therapies are an exciting emerging therapeutic modality with broad applicability across many indications. Originating from our leading iPSC platform, Evotec’s EVOcells platform enables the delivery of innovative cell therapeutics from inception to the patient. The acquisition of Rigenerand adds manufacturing capacity and expertise to the EVOcells platform. Our conversations with our partners as well as our own industry observations have made it clear that horizontal expansion and rapid iteration at the scale-up are critical within the cell therapy space,” stated Werner Lanthaler, Chief Executive Officer of Evotec.
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