Kristi Rosa

Lutetium Lu 177 dotatate shows consistent efficacy over high-dose octreotide in advanced GEP-NETs, according to data from the NETTER-2 trial.

Neoadjuvant TAR-200 plus cetrelimab elicited responses and was safe in muscle-invasive bladder cancer.

Taletrectinib elicited high and durable overall response rates with favorable tolerability in patients with advanced ROS1-positive NSCLC.

Pembrolizumab continued to demonstrate improved survival vs ipilimumab in unresectable stage III or IV melanoma.

Pembrolizumab plus chemoradiotherapy improved survival in previously untreated, high-risk locally advanced cervical cancer.

Treatment with belrestotug plus dostarlimab yielded a clinically meaningful improvement in ORR vs dostarlimab monotherapy in unresectable PD-L1–high NSCLC.

T-DXd showcased overall and intracranial activity in patients with HER2-positive metastatic breast cancer with stable and active brain metastases.

BMS-986012 plus nivolumab and chemotherapy provided a modest PFS benefit but signals of OS improvement in extensive-stage small cell lung cancer.

Rilvegostomig induced responses with acceptable tolerability in patients with checkpoint inhibitor-naive, metastatic NSCLC.

Brentuximab vedotin plus lenalidomide/rituximab significantly improved outcomes vs lenalidomide/rituximab alone in relapsed/refractory DLBCL.

The FDA has approved a new presentation of bortezomib for subcutaneous or intravenous administration.

ABD-147 has received orphan drug designation from the FDA for use in patients with neuroendocrine carcinoma.

Here is your snapshot of all therapeutic options that the FDA approved in August 2024 and their clinical implications.

Mirdametinib showed a statistically significant ORR by BICR, with deep and durable tumor volume reductions in adults and children with NF1-PN.

Encorafenib plus binimetinib has won approval from the European Commission for use in patients with BRAF V600E-mutated, advanced non–small lung cancer.

Oxaliplatin plus fluoropyrimidine and bevacizumab confers little therapeutic benefit to older patients with metastatic colorectal cancer.

Opaganib has received orphan drug designation from the FDA for use in patients with neuroblastoma.

Data from the INSIGHT 2 study showed that tepotinib plus osimertinib elicited responses in patients with EGFR-mutated non–small cell lung cancer.

Enfortumab vedotin plus pembrolizumab has been approved by Health Canada for use in unresectable locally advanced or metastatic urothelial cancer.

The FDA has issued a CRL to the BLA seeking approval of linvoseltamab for use in select patients with relapsed or refractory multiple myeloma.

GSK5764227 has received breakthrough therapy designation from the FDA for use in select patients with extensive-stage small cell lung cancer.

An NDA seeking approval of sacituzumab tirumotecan for select patients with EGFR+ non–small cell lung cancer has been accepted by the NMPA's CDE.

The European Commission has granted conditional marketing authorization to epcoritamab for patients with relapsed or refractory follicular lymphoma.

The FDA has granted orphan drug designation to PT217 for the treatment of patients with neuroendocrine carcinoma.

The EMA has expanded the indication for lisocabtagene maraleucel to include the treatment of patients with relapsed or refractory follicular lymphoma.

Enzalutamide led to improved OS, PCS, TTS, and TTR vs abiraterone acetate in patients with metastatic castration-resistant prostate cancer.

AC699 has won fast track designation from the FDA for select patients with ER-positive, HER2-negative, ESR1-mutated breast cancer.

Vebreltinib demonstrated preliminary activity in patients with non–central nervous system solid tumors harboring MET fusions.

A sNDA seeking the approval of toripalimab for frontline use in patients with unresectable or metastatic melanoma is under review by the NMPA.

Devimistat and modified fluorouracil, oxaliplatin, irinotecan, and leucovorin did not significantly improve short- or long-term outcomes over standard-dose FFX in metastatic pancreatic adenocarcinoma