European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

Approval is based on results from the Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in DFS, reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) after a median follow-up of 23.9 months compared to placebo, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high risk following nephrectomy and those with resected advanced disease)

Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

• KMMTRAK is the first and only FDA approved therapy for the treatment of unresectable or metastatic uveal melanoma (mUM)

• KIMMTRAK is the first T cell receptor (TCR) therapeutic to receive regulatory approval

• KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months

Gilead withdraw accelerated FL/SLL Zydelig® indications from US market; cites enrollment challenges.

Approval was based on a Phase 2 study in indolent non-Hodgkin lymphoma showing that 54% of those with FL and 58% of those with SLL had an objective response as assessed by an Independent Review Committee. Zydelig will remain on the market in the U.S. for CLL and for CLL and FL in the EU, UK, Canada, Australia, New Zealand, and Switzerland.

Friends of Cancer Research — Celebrating 25 years

Friends of Cancer Research started with 2 friends: Ellen Sigal & Marlene Malek. Their shared experience & commitment to change motivated them to create a partnership that would stand the test of time.

European Commission Grants Janssen Conditional MA for RYBREVANT (amivantamab) for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy

CMA is based on results from the Phase 1 CHRYSALIS study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy. ORR 37% (95% CI, 28% - 46%), with a median DoR of 12.5 months (95% CI, 6.5 – 16.1) and 64% of patients having a duration of response greater than or equal to 6 months

FDA approves rituximab plus chemotherapy for pediatric cancer indications

Approved in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

FDA approves daratumumab + hyaluronidase-fihj & carfilzomib plus dexamethasone for adult patients with r/r MM who have received 1 to 3 prior lines of therapy. ORR was 84.8% (95% CI: 73.9%, 92.5%). At a median follow-up of 9.2 months, the median DOR had not been reached and an estimated 85.2% (95% CI: 72.5, 92.3) maintained response for at least 6 months and 82.5% (95% CI: 68.9, 90.6) maintained response for at least 9 months.

TG Therapeutics, Inc. plans to host ODAC meeting in connection with its review of the pending BLA/sNDA for the combination of ublituximab and UKONIQ®

TG Therapeutics, Inc. | ODAC coming for under review combination of #ublituximab and #UKONIQ® (#umbralisib) in CLL and SLL; date to be confirmed. PDUFA goal date is March 25, 2022