Immuno-Oncology

The Cellular, Tissue, and Gene Therapies Advisory Committee will review Replimune’s twice-rejected BLA for RP1 plus nivolumab in advanced melanoma.

Laurence J. DiNardo, MD, FACS, discusses ctDNA testing in head and neck cancers, advancements in targeted therapies, and multidisciplinary collaboration.

Matthew Galsky, MD, discusses the FDA approval of perioperative pembrolizumab plus enfortumab vedotin in MIBC.

The phase 3 OptiTROP-Lung06 trial showed a PFS improvement with sac-TMT plus pembrolizumab in PD-L1–negative NSCLC.

The top 5 OncLive TV videos of the week cover insights in breast cancer, lymphoma, melanoma, prostate cancer, and ovarian cancer.

The FDA has approved new sacituzumab govitecan indications in TNBC, cleared palbociclib combination maintenance treatment in HER2-positive breast cancer, and more.

BI-1808 as a single agent and in combination with pembrolizumab elicited responses and was generally well tolerated in patients with CTCL.

Prespecified biomarker analyses of ASCENT-03 and ASCENT-04 showed longer PFS with sacituzumab govitecan–based regimens vs comparators in TNBC.

Ultra-low-dose nivolumab plus oral metronomic chemotherapy cut the risk of death by 43% versus paclitaxel-carboplatin in first-line platinum-sensitive recurrent or metastatic HNSCC.

The FDA approved adjuvant atezolizumab for muscle-invasive bladder cancer with circulating tumor DNA molecular residual disease.

First-line INBRX-106 plus pembrolizumab generated a higher ORR vs pembrolizumab monotherapy in PD-L1–positive metastatic or unresectable HNSCC.

The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.

Danvatirsen in combination with pembrolizumab did not result in an ORR improvement vs pembrolizumab alone in first-line recurrent/metastatic HNSCC.

Here is your cheat sheet to all oncology therapeutic options that were cleared or rejected by the FDA in April 2026.

The FDA grants priority review to enfortumab vedotin-ejfv sBLAs in MIBC, the review period for subcutaneous isatuximab BLA in myeloma has been extended, and more.

Pembrolizumab plus lenvatinib and belzutifan, as well as pembrolizumab/quavonlimab plus lenvatinib, did not extend OS or PFS in first-line ccRCC.

The FDA has granted priority review to the sBLAs for pembrolizumab and subcutaneous pembrolizumab plus enfortumab vedotin in cisplatin-eligible MIBC.

Sharon Castellino, MD, MSc, discusses the significance of the FDA approval of nivolumab plus AVD for stage III/IV classical Hodgkin lymphoma.

Tisotumab vedotin plus carboplatin & pembrolizumab ± bevacizumab achieved 65.8% ORR and 28-month median OS in first-line recurrent/metastatic cervical cancer.

The top 5 OncLive TV videos of the week cover insights in mantle cell lymphoma, chronic lymphocytic leukemia, salivary gland cancer, cholangiocarcinoma, and prostate cancer.

The FDA issued a CRL to RP1 plus nivolumab in advanced melanoma, accepted a NDA for the TLX101-Px imaging agent in glioma, and more.

Manish Patel, DO, discusses early evidence suggesting that AR inhibition may enhance the efficacy of immunotherapy in salivary gland cancer.

The FDA has cleared nivolumab/AVD for classical Hodgkin lymphoma, accepted a bezuclastinib NDA for review in nonadvanced systemic mastocytosis, and more.

Sarah Sammons, MD, discusses how pumitamig’s dual-protein targets position it as a unique agent within the TNBC treatment arena.

The top 5 OncLive TV videos of the week cover insights in mantle cell lymphoma, breast cancer, bladder cancer, head and neck cancer, and pancreatic cancer.