September 2024 Brief

This designation follows the fast track designation that was granted to OBX-115 for the same indication in July 2024.

The FDA has approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics to be used with olaparib, abiraterone, and prednisone or prednisolone BRCA-mutated metastatic castration-resistant prostate cancer.

The ready-to-use formulation of bortezomib is now an FDA-approved option for patients with multiple myeloma and mantle cell lymphoma.

IBI363 has earned fast track designation from the FDA for the treatment of previously treated unresectable advanced melanoma.

The novel agent VMT01 is designed to target and deliver 212Pb to MC1R-expressing tumors like metastatic melanoma.

The next-generation radiopharmaceutical ABD-147 was previously granted FDA fast track designation in extensive-stage small cell lung cancer.

The investigational agent certepetide has been granted FDA orphan drug designation for the treatment of patients with cholangiocarcinoma.

Tebapivat, a novel pyruvate kinase activator, is being investigated for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.

The FDA granted orphan drug designation for elraglusib, a novel drug for treating advanced soft tissue sarcoma.

The investigational new drug application for VNX-101, a gene therapy aimed at treating CD19-positive acute lymphoblastic leukemia, has been approved by the FDA.

The subcutaneous version of the cancer treatment atezolizumab is approved in all adult intravenous indications, including in lung, liver, and skin cancers.

Following promising preliminary findings from a phase 1 study, the FDA granted P-BCMA-ALLO1 regenerative medicine advanced therapy designation in relapsed/refractory multiple myeloma.

Adjuvant ribociclib plus an aromatase inhibitor is now an FDA-approved treatment in HR-positive, HER2-negative stage II and III early breast cancer at a high risk of recurrence.

ICT01 showed tolerable safety and promising clinical activity as a monotherapy and is now being investigated in combination with azacitidine and venetoclax in AML.

CF33-hNIS has gained FDA orphan drug designation for the treatment of cholangiocarcinoma and is currently being evaluated in the phase 1 MAST trial.

Following its initial approval at 150 mg, trastuzumab-strf has also been approved at 420 mg for the treatment of several HER2-overexpressing cancers.

The approval of amivantamab plus carboplatin and pemetrexed is supported by data from the phase 3 MARIPOSA-2 trial.

Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

The approval is supported by data from the phase 3 IMROZ study which demonstrated superior progression-free survival with isatuximab plus VRd vs VRd alone in patients with newly diagnosed, transplant-ineligible multiple myeloma.

The FDA granted fast track designation to EO-3021 for the treatment of advanced or metastatic gastric and gastroesophageal junction cancers expressing Claudin 18.2, which have progressed after prior therapy.

A new drug application has been resubmitted to the FDA for the combination of camrelizumab and rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma, following a complete response letter in May 2024.

The novel agent LP-184 has been granted rare pediatric disease designations in malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma.

Osimertinib is now an FDA-approved therapy for stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations that did not progress during or following platinum-based chemoradiation.

The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 expression less than 1.

A supplemental new drug application seeking expanded indication for darolutamide combined with androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer has been submitted to the FDA.

The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 expression less than 1.

The FDA granted traditional approval to selpercatinib for the treatment of advanced or metastatic RET-mutated medullary thyroid cancer in patients aged 2 years and older.

The FDA has approved the WATER IV PCa trial, which will compare the safety and efficacy of Aquablation therapy to radical prostatectomy in patients with localized prostate cancer.