Oncology

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

GT201 previously received IND clearance from China’s Center for Drug Evaluation in July 2023.

Review top news and interview highlights from the week ending August 30, 2024.

Among the treated patients, the complete response (CR) rate in adults was 82% and the CR rate in children was 93%.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The NMPA’s decision was made with reference to results from the phase 2 CARTIFAN-1 clinical trial (NCT03758417), which took place at multiple sites in China.

The approved indication specifically covers adults with r/r MCL who have previously been treated with at least 2 lines of systemic therapy including BTKis.

In light of the IND application, Galpagos intends to bring its phase 1/2 ATALANTA-1 clinical trial (NCT06561425), which is currently ongoing in Europe, to the United States.

Review top news and interview highlights from the week ending August 23, 2024.

The study was open to patients with advanced GC/GEJ whose disease was not successfully treated with 2 or more previous lines of therapy.

The company expects to launch a study during the first half of next year.

BMS is seeking to expand liso-cel's indication in the European Union to include adult patients with r/r FL who have previously received at least 2 prior lines of systemic therapy.

The company noted that the first 3 patients with enhanced host conditioning have been dosed in the CHIRON and THETIS trials evaluating ATL001.

Review top news and interview highlights from the week ending August 16, 2024.

The company reported promising early efficacy data from the Acclaim-1 and Acclaim-3 trials, but has discontinued Acclaim-2, citing difficulty enrolling patients.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

According to the company, the regulatory guidance came after a Type B meeting with the agency and pertains specifically to INB-100 for the treatment of AML.

BRG01 is the first cell therapy to move into a phase 2 clinical trial for relapsed/metastatic EBV-positive nasopharyngeal carcinoma in both the US and China.

For the 5 patients in long-term follow-up who have been evaluated, the average PFS is 4.8 months (range, 2-8 months).

TRX103 is also being evaluated for the prevention of graft versus host disease (GvHD) in patients undergoing HLA-mismatched HSCT.

Review top news and interview highlights from the week ending August 9, 2024.

Elderly patients were at higher risk of infections and subsequent malignant neoplasms.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

A recent study also recommended a shorter, more flexible monitoring period post-CAR–T therapy.