FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma

• 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile

• Sustained clinical benefit from Kymriah treatment demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months

• Kymriah can be administered in the outpatient setting, offering increased flexibility and potentially reducing the burden of therapy for patients and their care teams

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer; Israel included for the first time in Orbis-approval

• Median PFS was not reached (95% CI: 18.5, not estimable) in the Enhertu arm and 6.8 months (95% CI: 5.6, 8.2) in the ado-trastuzumab emtansine arm. The hazard ratio was 0.28 (95% CI: 0.22, 0.37; p-value<0.0001).

• This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, Israel’s Ministry of Health Pharmaceutical Administration, and Switzerland’s Swissmedic. The application reviews may be ongoing at the other regulatory agencies.

TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SL; UKONIQ AA withdrawn from market

• TG has voluntarily withdrawn the pending BLA/sNDA for the combo of ublituximab and UKONIQ® (umbralisib) combo in CLL/SLL

• Additionally, UKONIQ will be withdrawn for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies

• UKONIQ was granted accelerated approval in these indications in February 2021

European Commission Approval New Indications for Opdivo

EC approve new indications as follows:

• Opdivo (nivolumab) as Adjuvant Treatment for Patients with Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma with Tumor Cell PD-L1 Expression ≥1%

• Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1%

• Opdivo (nivolumab) with Chemotherapy as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1%

Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma

• The MA is based on results from the TRANSCEND NHL 001 study evaluating Breyanzi in adult patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease.

• In 216 patients treated with Breyanzi and evaluable for efficacy, 73% of patients achieved a response (95% CI: 67%-78.5%), including 53% who had minimal or no detectable lymphoma remaining following treatment (complete response [CR]; 95% CI: 47%-60%). Median duration of response was 20.2 months in all responders (95% CI: 8 – NR), and for patients who achieved a CR, median duration of response was 26.1 months (95% CI: 23 – NR).

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

EFS was significantly longer in the axicabtagene ciloleucel arm with a HR of 0.40 (95% CI: 0.31, 0.51; stratified p-value <0.0001). The estimated 18-month EFS rate was 41.5% (95% CI: 34.2, 48.6) in the axicabtagene ciloleucel arm and 17.0% (95% CI: 11.8, 23.0) in the standard therapy arm.

FDA approves olaparib for adjuvant treatment of high-risk early breast cancer

For IDFS, there were 106 events (12%) in the olaparib arm and 178 events (20%) in the placebo arm (HR 0.58; 95% CI: 0.46, 0.74; p<0.0001). IDFS at 3 years was 86% (95% CI: 82.8, 88.4) for patients receiving olaparib and 77% (95% CI: 73.7, 80.1) for those receiving placebo.

TG Therapeutics Announces ODAC, 22 April 2022

FDA has set a date of April 22, 2022 for the previously announced ODAC in connection with its review of the BLA/sNDA for the combination of ublituximab and UKONIQ® (umbralisib) in CLL/SLL.