Kristi Rosa

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.

The FDA has granted regular approval to mirvetuximab soravtansine-gynx for select patients with pretreated FRα-positive, platinum-resistant ovarian cancer.

PT886 has been granted fast track designation for use as a potential therapeutic option in patients with metastatic claudin 18.2–positive pancreatic adenocarcinoma.

Becotarug plus osimertinib elicited responses with manageable safety in patients with non–small cell lung cancer and EGFR exon 12 insertion mutations.

Rezatapopt induced responses with acceptable toxicity in heavily pretreated patients with advanced ovarian cancer harboring TP53 Y220C mutations.

The FDA has granted accelerated approval to ponatinib (Iclusig) in combination with chemotherapy for the treatment of adult patients with newly diagnosed, Philadelphia chromosome–positive acute lymphoblastic leukemia.

The FDA has granted accelerated approval to lisocabtagene maraleucel for the treatment of select patients with relapsed/refractory CLL or SLL.

The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.

Tinengotinib has been awarded orphan drug designation from the European Medicines Agency for use in select patients with biliary tract cancer.

The FDA's Medical Imaging Drugs Advisory Committee voted 16 to 2 in support of the benefit-risk profile of Lumisight.

Cambritaxestat has received orphan drug designation from the FDA for the treatment of patients with pancreatic cancer.

The FDA has approved nivolumab plus cisplatin and gemcitabine for first-line use in adult patients with unresectable or metastatic urothelial carcinoma.

The FDA has approved inotuzumab ozogamicin for pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.