The OncFive: Top Oncology Articles for the Week of 7/13

July 19, 2025

Glofitamab received a CRL from the FDA in R/R DLBCL, ODAC voted against belantamab mafodotin in R/R multiple myeloma, and more.

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Issues CRL for Glofitamab Plus Chemo in R/R DLBCL

Following a negative recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in May 2025, the regulatory agency ultimately issued a complete response letter (CRL) to the supplemental biologics license application (sBLA) seeking the approval of glofitamab-gxbm (Columvi) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have received at least 1 prior line of therapy and who are not candidates for autologous stem cell transplant (ASCT).

The CRL outlined the same issue highlighted by ODAC, noting that data from the phase 3 STARGLO trial (NCT04408638) did not provide enough evidence to support the regimen's approval in the United States population. Glofitamab still has accelerated approval for the treatment of patients relapsed/refractory DLBCL not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after at least 2 lines of systemic therapy.

The phase 3 SKYGLO study (NCT06047080) will serve as the new post-marketing confirmatory study for glofitamab. The trial is investigating the agent in combination with polatuzumab vedotin-piiq (Polivy), rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated LBCL.

FDA’s ODAC Votes Against Risk:Benefit Profiles of Belantamab Mafodotin Combos in R/R Myeloma

In a separate ODAC meeting held on July 17, 2025, the committee issued 2 additional negative recommendations for pair of belantamab mafodotin (Blenrep)–based combinations. ODAC voted 5 to 3 against the risk:benefit profile of the proposed dosage of belantamab mafodotin in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy; and 7 to 1 against the risk:benefit profile of the proposed dosage of belantamab mafodotin in combination with pomalidomide (Pomalyst) and dexamethasone for patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide (Revlimid).

FDA’s Published CRLs Deliver Insight Into the Drug Approval Process

After the regulatory agency published 202 CRLs for applications seeking the approval of drugs or biologic products earlier in July 2025, OncLive combed through the oncology-related CRLs and broke down these FDA decisions. Take a deep dive into these CRLs and how other regulatory decisions ultimately stemmed from them.

Pembrolizumab/Lenvatinib Combination Produces Durable Responses in Advanced Non–Clear Cell RCC

The 2025 Kidney Cancer Research Summit wrapped up on Friday—be sure to catch up on any coverage you missed here. Among the presentations, Laurence Albiges MD, PhD, of Institut Gustave Roussy, provided an update on the phase 2 KEYNOTE-B61 trial (NCT04704219) evaluating the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) in patients with advanced non–clear cell renal cell carcinoma (RCC).

Findings from the updated analysis demonstrated that evaluable patients (n = 152) achieved an overall response rate (ORR) of 50.6% (95% CI, 42.6%-58.7%), a disease control rate (DCR) of 82.3% (95% CI, 75.4%-87.9%), and a clinical benefit rate (CBR) of 71.5% (95% CI, 63.8%-78.4%). The complete responses and partial response rates were 10.1% and 40.5%, respectively.

Luspatercept Plus Concomitant JAK Inhibitor Therapy Misses Primary End Point in Myelofibrosis-Associated Anemia

Treatment with luspatercept-aamt (Reblozyl) with concomitant JAK inhibitor therapy did not meet the primary end point of red blood cell (RBC) transfusion independence during any consecutive 12-week period in adult patients with myelofibrosis-associated anemia receiving RBC transfusions, according to topline data the phase 3 INDEPENDENCE trial (NCT04717414).