Your AI-Trained Oncology Knowledge Connection!
Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The FDA has approved inotuzumab ozogamicin for pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
The FDA has approved amivantamab plus chemotherapy for the frontline treatment of select patients with EGFR exon 20 insertion+ non–small cell lung cancer.
In case you missed it, below is a recap of all drugs that have been approved by the FDA in February 2024.
Lisocabtagene maraleucel elicited durable responses in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA granted an orphan drug designation to ocifisertib for use as a potential therapeutic option in patients with acute myeloid leukemia.
Neoadjuvant tislelizumab plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab demonstrated efficacy in resectable non–small cell lung cancer.
The FDA has approved osimertinib (Tagrisso) plus chemotherapy for use in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.
The FDA has approved lifileucel suspension (Amtagvi) for adult patients with unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor, and if BRAF V600 mutation positive, a BRAF inhibitor, with or without a MEK inhibitor.
The FDA has granted approval to tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.
The FDA has approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin, for the frontline treatment of metastatic pancreatic adenocarcinoma.
Adjuvant nivolumab significantly improved relapse-free survival vs ipilimumab in resected stage III/IV melanoma, according to 7-year minimum follow-up.
The EMA is evaluating a Type II extension of indication application for the approval of first-line amivantamab plus lazertinib in EGFR-mutated NSCLC.
NXC-201 has received orphan drug designation from the European Commission for use in patients with amyloid light-chain amyloidosis.
The phase 3 ENHANCE-3 study of magrolimab plus venetoclax/azacitidine vs venetoclax/azacitidine in select patients with AML has been terminated.
The FDA and EMA have accepted applications seeking the approval of neoadjuvant nivolumab/chemotherapy followed by surgery and adjuvant nivolumab in NSCLC.
Fruquintinib/paclitaxel significantly improved PFS but not OS vs paclitaxel alone in the second-line treatment in patients with advanced gastric cancer.
Vepdegestrant has received FDA fast track designation for select patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.
Tinengotinib elicited responses with a manageable safety profile in heavily pretreated patients with metastatic castration-resistant prostate cancer.
Health Canada will review the new drug submission seeking the approval of momelotinib in patients with myelofibrosis.
The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.
Efineptakin alfa received an orphan drug designation from the FDA for use as a potential therapeutic option in patients with pancreatic cancer.
A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.
The combination of SCO-101 and FOLFIRI resulted in tumor reduction and increased progression-free survival in patients with metastatic colorectal cancer.
An acceptable safety profile and early evidence of clinical activity was observed with ziftomenib plus standard regimens in select patients with AML.
The FDA granted priority review to a sNDA seeking the approval of alectinib as adjuvant treatment after surgery for early-stage ALK-positive NSCLC.
Liso-cel sBLAs for indications in relapsed/refractory FL and MCL after exposure to a BTK inhibitor have received priority review from the FDA.
Pembrolizumab plus cabozantinib was efficacious in the first-line treatment of patients with cisplatin-ineligible urothelial carcinoma.
The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.
KVA12123 demonstrated early signals of on-target activity and tolerability at all dose levels examined to date in patients with advanced solid tumors.
The FDA has accepted for review the BLA for obecabtagene autoleucel's use in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
