Kristi Rosa

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.

CT041 was safe and showcased early signals of antitumor activity in heavily pretreated patients with metastatic pancreatic cancer.

Perioperative pembrolizumab plus chemotherapy improved survival vs preoperative chemotherapy in high-risk, early-stage, triple-negative breast cancer.

Atezolizumab plus chemotherapy did not improve OS vs chemotherapy alone in select patients with early relapsing triple-negative breast cancer.

In case you missed it, below is your guide to the important regulatory approvals made by the FDA in April 2024.

Fuzuloparib with or without apatinib provided superior PFS benefit vs chemotherapy in HER2– metastatic breast cancer harboring germline BRCA1/2 mutations.

China's NMPA has granted breakthrough therapy designation to IBI343 for use in select patients with claudin 18.2–positive gastric or GEJ adenocarcinoma.

The zenocutuzumab BLA for patients with NRG1-positive non–small cell lung cancer and pancreatic cancer has received priority review from the FDA.

Treatment with loncastuximab tesirine yielded high response rates in patients with relapsed or refractory marginal zone lymphoma.

In case you missed it, these were the key regulatory decisions made by the FDA in March 2024.