The OncFive: Top Oncology Articles for the Week of 3/8

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FDA Indications for Tazemetostat in R/R Follicular Lymphoma and Epithelioid Sarcoma Are Voluntarily Withdrawn

Ipsen announced that it is voluntarily withdrawing the FDA indications for tazemetostat (Tazverik) for the treatment of patients with relapsed or refractory follicular lymphoma and those with epithelioid sarcoma.

The decision was based on data from the ongoing phase 1b/3 SYMPHONY trial (NCT04224493) evaluating tazemetostat plus lenalidomide (Revlimid) and rituximab (Rituxan; R²) in patients with relapsed or refractory follicular lymphoma. An independent data monitoring committee concluded that risks for the safety of patients due to adverse effects (AEs) of secondary hematologic malignancies outweigh the benefits of tazemetostat. The agent had previously received accelerated approval from the FDA in the follicular lymphoma and epithelioid sarcoma indications in 2020.

FDA Grants Priority Review to Post-Neoadjuvant T-DXd for HER2+ Early Breast Cancer

The FDA granted priority review to a supplemental biologics license application (sBLA) seeking the approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant HER2-targeted treatment.

The sBLA is supported by data from the phase 3 DESTINY-Breast05 trial (NCT04622319), which demonstrated that patients treated with T-DXd (n = 818) experienced a 53% reduction in the risk of disease progression or death compared with patients who received ado-trastuzumab emtansine (T-DM1; Kadcyla; n = 817; HR, 0.47; 95% CI, 0.34-0.66; P < .0001).

The FDA has assigned a target action date of July 7, 2026, under the Prescription Drug User Fee Act.

FDA Issues CRL for Retifanlimab Plus Chemotherapy in Metastatic NSCLC

The FDA issued a complete response letter (CRL) for an sBLA seeking the approval of retifanlimab-dlwr (Zynyz) in combination with platinum-containing chemotherapy for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC).

The CRL stemmed from inspection findings from a third-party fill-finish facility, not the efficacy or safety data submitted. Incyte, the developers of the agent, plan to work closely with the FDA and the Catalent Indiana facility to address the CRL and support a potential sBLA submission for retifanlimab in NSCLC.

Mezigdomide Plus Kd Hits Phase 3 PFS End Point in R/R Myeloma

The addition of mezigdomide (CC-92480) to carfilzomib (Kyprolis) and dexamethasone (Kd) led to a statistically significant improvement in progression-free survival (PFS) compared with Kd alone in patients with relapsed/refractory multiple myeloma, meeting the primary end point of the phase 3 SUCCESSOR-2 trial (NCT05552976).

Safety data for mezigdomide plus Kd were consistent with the known safety profile of the agent and the combination regimen. Data from SUCCESSOR-2 will be presented at an upcoming medical conference and shared with global health authorities.

sBLA for Nogapendekin Alfa Inbakicept in Papillary BCG-Unresponsive NMIBC Is Resubmitted to FDA

The FDA has received a resubmitted sBLA seeking the approval of nogapendekin alfa inbakicept-pmln (Anktiva) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with papillary-only tumors.

In a January 2026 Type B end-of-phase meeting, the FDA requested additional data to support the review of the sBLA after the FDA issued a refusal to file letter for the initial submission in May 2025. The regulatory body did not ask for the initiation or design of any new clinical trials. The resubmitted sBLA for patients with papillary-only NMIBC includes long-term follow-up data from cohort B of the phase 2/3 QUILT-3.032 trial (NCT03022825), which supported submission.Plus Pembrolizumab in ccRCC Earns Priority Review From FDA

The FDA granted priority review to supplemental applications seeking approval of belzutifan (Welireg) plus pembrolizumab (Keytruda) or pembrolizumab with berahyaluronidase alfa for adjuvant treatment of patients with high-risk clear cell renal cell carcinoma (ccRCC) after nephrectomy. The filings are supported by data from the phase 3 LITESPARK-022 trial (NCT05239728), which showed improved disease-free survival (DFS) with pembrolizumab plus belzutifan (n = 921) vs pembrolizumab alone (n = 920; HR, 0.72; 95% CI, 0.59-0.87; P = .0003). At interim analysis, the combination demonstrated higher 12- (91.9% vs 85.2%), 24- (80.7% vs 73.7%), and 30- (75.8% vs 68.6%) month DFS rates vs monotherapy. OS data remain immature, and the FDA has set a decision date of June 19, 2026, under the Prescription Drug User Fee Act.