Legend and Johnson & Johnson have expanded a previous manufacturing agreement with Novartis to perform commercial production of CAR-T drug Carvykti.
Basel, June 12, 2022 — Novartis today announced long-term results from the ELIANA pivotal clinical trial of Kymriah® (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years. For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months. These findings demonstrate the curative potential of Kymriah, the only CAR-T cell therapy available for these patients who previously had limited treatment options. These data were presented as an oral presentation during the 2022 European Hematology Association (EHA) Hybrid Congress (Abstract #S112)1.
EAST HANOVER, N.J., May 27, 2022 /PRNewswire/ -- Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings1.
Basel, May 4, 2022 — Novartis announced today that the European Commission (EC) has approved Kymriah® (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval follows a positive opinion in March by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. This approval marks the third indication for Kymriah and makes it the first CAR-T cell therapy approved in the EU for these patients, which include those with r/r FL grade 1, 2 and 3A1.
Kymriah’s shocking failure in earlier lymphoma treatment has raised doubts about the Novartis drug’s potency in light of impressive victories from rival CAR-Ts by Gilead Sciences and Bristol Myers Squibb. With detailed data now coming in, the Swiss pharma believes it has a pretty good idea what went wrong.
Blackstone Inc. is investing as much as $250 million in U.K. biotechnology company Autolus Therapeutics PLC to fund the final stages of development of a new therapy to treat a serious form of leukemia, the companies said.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have both respectively accepted Novartis’ Kymriah for review as a treatment for adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two lines of prior treatment.
CRISPR Therapeutics provided updated data from its ongoing Phase I CARBON trial of CTX110, its allogeneic “off-the-shelf” CAR-T therapy for CD19+ B-cell cancers. The data is based on 26 of 30 patients who, as of August 26, 2021, a data cutoff date, had received the therapy with at least 28 days of follow-up.
ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced that the first patient has been dosed in a Phase 1b study of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), following CAR-T cell therapy tisagenlecleucel (Kymriah®) in patients with relapsed/refractory (r/r) Large B-Cell Lymphoma (LBCL).