Immuno-Oncology | Specialty

OncLive’s FDA Approval Report: The Regulatory Rundown for March 2025

April 2nd 2025

Here is your snapshot for all therapeutic options that were approved by the FDA in March 2025 spanning tumor types.

Tisotumab Vedotin Earns European Approval for Pretreated Recurrent/Metastatic Cervical Cancer

April 1st 2025

Tisotumab vedotin was granted approval by the EU for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Dr Mateos on Long-Term OS Data From the Phase 3 CARTITUDE-4 Study of Cilta-Cel in Lenalidomide-Refractory Multiple Myeloma

April 1st 2025

María-Victoria Mateos, MD, PhD, discusses long-term OS data from the CARTITUDE-4 trial of cilta-cel in lenalidomide-refractory multiple myeloma.

Pembrolizumab Plus cCRT Elicits Durable Antitumor Activity in Unresectable Stage III NSCLC

April 1st 2025

Updated KEYNOTE-799 data continued to show robust activity with pembrolizumab plus concurrent chemoradiation in unresectable stage III NSCLC.

The OncFive: Top Oncology Articles for the Week of 3/23

March 29th 2025

The FDA cleared therapeutic options in pNETs/epNETs, MIBC, and mCRPC; experts highlight top abstracts ahead of 2025 EBMT; and more from OncLive.

FDA Approves Perioperative Durvalumab Plus Chemo for Muscle-Invasive Bladder Cancer

March 28th 2025

The FDA approved perioperative durvalumab plus chemotherapy for muscle-invasive bladder cancer.

CHMP Offers Positive Opinion for Perioperative Nivolumab Plus Chemo in Resectable PD-L1+ NSCLC

March 28th 2025

The EMA’s CHMP has recommended the approval of perioperative nivolumab plus chemotherapy in resectable PD-L1–positive non–small cell lung cancer.

Frontline Fulzerasib Plus Cetuximab Elicits Deep, Durable Responses in KRAS G12C–Mutated NSCLC

March 28th 2025

Fulzerasib plus cetuximab elicited deep efficacy in patients with KRAS G12C–mutated NSCLC enrolled in the phase 2 KROCUS study.

Adagrasib Combo Continues to Show Efficacy in KRAS G12C–Mutated NSCLC and PD-L1 ≥50%

March 28th 2025

Adagrasib plus pembrolizumab continued to show promising efficacy in patients with KRAS G12C–mutated NSCLC and PD-L1 TPS of 50% or higher.

Nemvaleukin Fails to Show OS Benefit Over Chemotherapy in Platinum-Resistant Ovarian Cancer

March 25th 2025

The development of nemvaleukin in platinum-resistant ovarian cancer will be discontinued based on interim OS data from the phase 3 ARTISTRY-7 trial.

The OncFive: Top Oncology Articles for the Week of 3/16

March 22nd 2025

Pembrolizumab combination gets full approval in select HER2+ gastric/GEJ cancer, PSMA PET imaging agent is cleared for prostate cancer, and more from OncLive.

FDA Approves Pembrolizumab Plus Trastuzumab/Chemo for PD-L1+, HER2+ Gastric/GEJ Adenocarcinoma

March 19th 2025

The FDA approved pembrolizumab, trastuzumab, and chemotherapy for HER2-positive, PD-L1–positive gastric/GEJ adenocarcinoma.

Pembrolizumab Produces Durable Responses in Chemo-Pretreated Clear Cell Gynecologic Cancers

March 13th 2025

Treatment with pembrolizumab monotherapy was effective and well tolerated in pretreated patients with advanced clear cell gynecologic cancers.

INB-100 Following HSCT Displays Long-Lasting Activity in Pretreated AML

March 12th 2025

The γδ T-cell agent INB-100 demonstrated a 100% relapse-free survival rate in patients with AML.

Nivolumab Plus Ipilimumab Receives EC Approval for First-Line Unresectable HCC

March 7th 2025

Nivolumab plus ipilimumab was approved by the European Commission for first-line, unresectable or advanced HCC.

Versamune HPV–Based Immunotherapy Combo Demonstrates Benefit in Advanced HPV-Associated Cancers

March 6th 2025

Versamune HPV plus PDS01ADC and bintrafusp alfa demonstrated clinical benefit in locally advanced or metastatic HPV-associated cancers.

Nivolumab/Ipilimumab Combination Represents Potential Standard-of-Care Shift in MSI-H/dMMR mCRC

March 5th 2025

Thierry André, MD, discusses findings from the phase 3 CheckMate 8HW trial of nivolumab plus ipilimumab in MSI-H/dMMR mCRC.

CHMP Recommends Perioperative Durvalumab Regimen in Resectable NSCLC

March 3rd 2025

The CHMP has recommended the approval of perioperative durvalumab plus neoadjuvant chemotherapy for patients with resectable NSCLC.

Five Under 5: Top Oncology Videos for the Week of 2/23

March 2nd 2025

The top 5 videos of the week cover insights in ovarian cancer, NSCLC, CSCC, follicular lymphoma, and CLL.

The OncFive: Top Oncology Articles for the Week of 2/23

March 1st 2025

Perioperative pembrolizumab sBLA gets priority review in HNSCC, nivolumab/ipilimumab sBLA in MSI-H/dMMR CRC is under review, and more from OncLive this week.

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