TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SL; UKONIQ AA withdrawn from market

• TG has voluntarily withdrawn the pending BLA/sNDA for the combo of ublituximab and UKONIQ® (umbralisib) combo in CLL/SLL

• Additionally, UKONIQ will be withdrawn for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the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

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

ORR was 97.9% (95% CI: 92.7%, 99.7. Among the 95 patients who responded, the median duration of response (DOR) was 21.8 months (95% CI: 21.8, NE) with a median duration of follow up of 18 months.

European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer

The approval for the first-line use of LORVIQUA was based on the results of the pivotal Phase 3 CROWN trial, in which LORVIQUA reduced the risk of disease progression or death by 72% compared to XALKORI® (crizotinib). As a secondary endpoint, the confirmed objective response rate (ORR) was 76% (95% CI, 68 to 83) with LORVIQUA and 58% (95% CI, 49 to 66) with XALKORI. In patients with measurable brain metastases, 82% of patients in the LORVIQUA arm experienced an intracranial response (71% had an intracranial complete response), compared to 23% of XALKORI patients. The CROWN trial is a randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive LORVIQUA monotherapy (n=149) or XALKORI monotherapy (n=147).