March 2024 Brief

JAB-30300, a P53 Y220C activator, received approval from the FDA for its investigational new drug application. A phase 1/2a clinical trial to investigate its safety and efficacy against advanced solid tumors will begin.

Amivantamab plus carboplatin and pemetrexed is now an approved first-line treatment for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer.

Following the development of further safety and monitoring protocols, the IOV-LUN-202 trial can resume patient enrollment.

The novel cell therapy A2B530 is the first logic-gated cell therapy aimed at selectively killing tumor cells and protecting healthy cells in colorectal cancer.

The FDA has initiated a rolling submission for mirdametinib, an investigational MEK inhibitor, for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas in pediatric and adult patients.

The first-in-human study that has received FDA clearance will investigate the novel autologous Innocell vaccine in stage III/IV ovarian cancer.

The FDA approved the investigational new drug application for olaptesed pegol as a potential treatment for adult patients with aggressive brain cancer, specifically glioblastoma.

The investigational new drug application for CLN-619 has been granted clearance from the FDA, marking it as a potential for the treatment of relapsed/refractory multiple myeloma.

The FDA orphan drug designation qualifies the sponsor of avutometinib for tax credits for clinical trials, exemption from user fees, and potential market exclusivity.

The FDA has approved inotuzumab for the treatment of pediatric patients 1 year or older with acute lymphoblastic leukemia.

Cambritaxestat, a first-in-class therapy in development for highly fibrotic cancer indications that overexpress autotaxin, has been granted an orphan drug designation from the FDA in pancreatic cancer.

Nivolumab given with cisplatin-based chemotherapy has received approval from the FDA for patients with treatment-naive unresectable or mUC.

Following changes to the manufacturing process, the phase 1 study of NX-2127 in B-cell malignancies has been cleared to continue by the FDA.

The BCR-ABL tyrosine kinase inhibitor TERN-701 has been granted an orphan drug designation from the FDA for the treatment of chronic myeloid leukemia.

The FDA has accepted the new drug application of ensartinib for the treatment of patients with metastatic ALK-positive non-small cell lung cancer.

The FDA granted orphan drug designation to LYT-200, a drug being investigated for treating acute myeloid leukemia.

The Oncologic Drug Advisory Committee of the FDA found that imetelstat has robust data supporting its use for transfusion-dependent anemia in patients with myelodysplastic syndromes.

The FDA approved tislelizumab alone for patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy not including a PD-1/PD-L1 inhibitor.

During an Oncologic Drugs Advisory Committee Meeting, the FDA found that ciltacabtagene autoleucel has a favorable benefit/risk profile in relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy and are refractory to lenalidomide.

The result of the FDA's Oncologic Drug Advisory Committee vote on idecabtagene vicleucel for the proposed indication is favorable.

P-BCMA-ALLO1 was granted an FDA orphan drug designation for the treatment of patients with relapsed/refractory multiple myeloma and is being evaluated in a phase 1 trial.

If approved, denileukin diftitox could offer a valuable addition to the treatment landscape of relapsed/refractory cutaneous T-cell lymphoma.

Ponatinib in combination with chemotherapy is now an approved treatment option for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The FDA fast-tracked MVR-T3011, an intratumorally injected oncolytic virus, for treating recurrent or metastatic head and neck squamous cell cancer post-platinum chemotherapy and at least 1 prior anti-PD1/PDL1 therapy.

A fast track designation from the FDA has been given to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.

The FDA strengthened safety warnings for fluorouracil due to dihydropyrimidine dehydrogenase deficiency that can cause severe adverse effects.

Mirvetuximab soravatansine is now FDA-approved for the treatment of patients with folate receptor alpha-positive, platinum-resistant ovarian cancer

A phase 2 trial plans to evaluate BAT8006 for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The FDA issued a pair of complete response letters for the biologics license application for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

Revumenib, a first-in-class Menin inhibitor, was granted priority review from the FDA for the treatment of adult and pediatric relapsed or refractory KMT2A-rearranged acute leukemia.

With the FDA clearance of an investigational new drug application, a phase 1 clinical trial evaluating NST-628 will start in mid-2024.

Here is a look back at all the FDA happenings of March 2024.