OR WAIT null SECS
NCCN adds Rylaze to guidelines soon after was approved by the FDA and a British company reports positive results for its CAR-T therapy.
According to the National Cancer Institute, acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children, accounting for 25% of cancer diagnoses among children younger than 15 years. But the disease affects adults, too. Roughly 4 in 10 cases occur in adults and most (80%) of the deaths from ALL occur in adults, according to the American Cancer Society.
The National Comprehensive Cancer Network for ALL recently added Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the clinical practice guidelines for the disease for both pediatric and adult patients. Rylaze is included as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multiagent chemotherapeutic regimen to complete the full treatment course. Rylaze was approved by the FDA on June 30, 2021, and the only alternative has been on global shortage since 2016.“Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence. We are pleased by the NCCN’s decision to quickly incorporate Rylaze into the clinical practice guidelines for ALL,” said Rob Iannone, M.D., MSCE, executive vice president, research, and development and chief medical officer at Jazz Pharmaceuticals in a press release.
Autolus Therapeutics, a British biotech company, is developing a CAR-T therapy that might be effective against ALL. The company announced positive promising data for adult ALL patients at the European Hematology Association Virtual Congress 2021 for the treatment, which it is calling AUTO1 (obecabtagene autoleucel). Obecabtagene autoleucel gets shortened obe-cel.
As of the data cut-off date of May 17, 2021, 20 patients with relapsed/refractory ALL had received obe-cel. The therapy was well tolerated, and no patients experienced grade 3 or higher cytokine release syndrome (CRS), according to the company. CRS is a condition that can occur after treatment with certain types of immunotherapy, and symptoms can include fever, nausea, headache, rash, fast heartbeat, low blood pressure, and trouble breathing.Of the 20 patients evaluated for efficacy, 17 (85%) achieved minimum residual disease-negative complete remission at one month. Across all treated patients, event-free survival (EFS) at 12 months and 24 months is 50.2% with median EFS not being achieved.
On Monday, the company announced that it had received a promising innovative medicine (PIM) indication from the British drug regulators. The PIM designation might mean early access to treatment in the United Kingdom.