Kristi Rosa

Trastuzumab deruxtecan elicited responses in patients with HER2-positive biliary tract cancer, according to data from a single-arm, phase 2 trial.

The FDA granted an orphan drug designation to the combination of avutometinib and defactinib for use as a potential therapeutic option in patients with pancreatic cancer.

The FDA approved Darzalex Faspro plus VRd for induction and consolidation in select patients with newly diagnosed multiple myeloma.

Frontline pembrolizumab, carboplatin, and paclitaxel demonstrated antitumor activity in recurrent or metastatic head and neck squamous cell carcinoma.

The EMA's CHMP has recommended zolbetuximab plus chemotherapy in select locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer.

NICE recommends pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric or GEJ adenocarcinoma.

Atezolizumab administered before and following chemoradiation appeared to be safe and efficacious in unresectable stage III non–small cell lung cancer.

Bintrafusp alfa elicited responses in patients with recurrent/metastatic cervical cancer, warranting further exploration of TGF-β-targeted therapies.

The marketing authorization application seeking the approval of vimseltinib for the treatment of tenosynovial giant cell tumor is under EMA review.

The EMA has accepted a marketing authorization application seeking approval of belantamab mafodotin regimens in relapsed/refractory multiple myeloma.

RMC-6236 led to early antitumor activity with an acceptable safety profile in patients with previously treated pancreatic ductal adenocarcinoma.

The FDA has granted fast track designation to CT-0525 for the treatment of patients with HER2-overexpressing solid tumors.

Treatment with single-agent abemaciclib (Verzenio) did not demonstrate clinically meaningful activity in heavily treated patients with metastatic clear cell renal cell carcinoma.

Paxalisib improved OS over SOC in patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status.

Data from the phase 2 REGINA trial support further investigation of neoadjuvant regorafenib, nivolumab, and SCRT in locally advanced rectal cancer.

Here is your guide to the important regulatory decisions made by the FDA in June 2024.

The EMA recommends durvalumab plus chemotherapy, followed by olaparib and durvalumab for pMMR endometrial cancer, and single-agent durvalumab for dMMR disease.

The EMA's CHMP has adopted a positive opinion regarding erdafitinib in patients with FGFR3+ unresectable or metastatic urothelial carcinoma.

The FDA has approved a new drug application for Tepylute, a ready-to-dilute formulation to treat breast and ovarian cancers.

The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

The Ministry of Health, Labour, and Welfare in Japan has approved momelotinib for use in patients with myelofibrosis.

MB-106 showcased a favorable safety profile and elicited responses in heavily pretreated patients with refractory Waldenström macroglobulinemia.

ROCSAN step 1 did not meet its primary end point of 16-week response rate with niraparib or dostarlimab/niraparib in endometrial/ovarian carcinosarcoma.

Linvoseltamab induced durable responses in patients with relapsed or refractory multiple myeloma, including those with high-risk features.

Adding fixed-duration glofitamab-gxbm (Columvi) to gemcitabine and oxaliplatin led to a statistically significant and clinically meaningful improvement in survival vs rituximab (Rituxan) plus gemcitabine/oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplant.

The FDA has approved blinatumomab (Blincyto) for use in select patients with CD19+ Ph– B-cell precursor acute lymphoblastic leukemia in the consolidation phase.

Blinatumomab consolidation improved MRD clearance over chemotherapy in DS B-ALL patients, according to ALLTogether1 DS study results.

The FDA granted accelerated approval to repotrectinib (Augtyro) for select patients with solid tumors harboring a NTRK gene fusion.

The European Commission has approved alectinib for adjuvant use in adult patients with ALK+ non–small cell lung cancer at high risk of recurrence.

The FDA has approved imetelstat (Rytelo) for select patients with myelodysplastic syndrome and transfusion-dependent anemia.