Kristi Rosa

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.

Petosemtamab paired with pembrolizumab had early clinical efficacy when used as first-line treatment in select head and neck squamous cell carcinoma

Neoadjuvant nivolumab with chemotherapy led to durable EFS benefit and a trend toward improved OS vs chemotherapy alone in patients with resectable NSCLC.

Pembrolizumab plus sacituzumab govitecan numerically improved PFS vs the ADC alone in HR-positive, HER2-negative metastatic breast cancer.

Consolidation treatment with durvalumab after concurrent chemoradiation led to a survival benefit vs placebo in limited-stage small cell lung cancer.

Abemaciclib plus fulvestrant improved PFS vs fulvestrant alone in select patients with hormone receptor–positive/HER2-negative advanced breast cancer.

The addition of pelabresib and ruxolitinib (Jakafi) led to a significant and durable reduction in splenomegaly, among other improvements, vs ruxolitinib alone in JAK inhibitor–naive patients with myelofibrosis.

Ponatinib generated long-term efficacy and displayed manageable safety in chronic-phase chronic myeloid leukemia harboring a T315I mutation.

Here is your guide to important regulatory approvals made by the FDA in May 2024.

The FDA has granted accelerated approval to selpercatinib for pediatric patients with select RET-altered metastatic thyroid cancers or solid tumors.

The European Commission approved nivolumab plus cisplatin and gemcitabine for first-line treatment in unresectable or metastatic urothelial carcinoma.