Kristi Rosa

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.

Phase 1 data of TG4050 elicited tumor-specific immune responses that resulted in low relapse rates in patients with resected HPV–negative head and neck cancers.

The NMPA of China has approved toripalimab plus axitinib for use in the first-line treatment of patients with medium- to high-risk unresectable or metastatic RCC.

Linvoseltamab elicited responses with acceptable safety in patients with relapsed/refractory multiple myeloma, including difficult-to-treat subsets

The FDA has approved cilta-cel for select patients with relapsed/refractory multiple myeloma who have received at least 1 line of therapy, and who are lenalidomide refractory.

The FDA has approved ide-cel (Abecma) for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy.

Phase 2 data from the AUGMENT-101 study show that revumenib elicits responses with acceptable safety in pediatric patients with KMT2A+ acute leukemia.

The EMA has accepted a MAA seeking the approval of obe-celf or use in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia.

Voruciclib plus venetoclax had antileukemic activity with acceptable safety in patients with relapsed or refractory acute myeloid leukemia.

MK-1084 had an acceptable toxicity profile when administered as a monotherapy in patients with KRAS G12C–mutated previously treated solid malignancies.