Sabrina Serani

The 2024 International Myeloma Society Annual Meeting was a groundbreaking event that showcased the latest advancements in multiple myeloma research and treatment.

Acalabrutinib, a BTK inhibitor, has shown promising results in treating mantle cell lymphoma, with the FDA granting it priority review.

Here is a look back on all the FDA happenings from the month of September 2024.

Results from cohort 2 of the TROPHY-U-01 study showed that sacitizumab govitecan led to rapid responses in patients with locally advanced or metastatic urothelial carcinoma.

A new CAR T-cell therapy, durcabtagene autoleucel, showed promising results in treating relapsed/refractory multiple myeloma with high response rates and manageable adverse effects.

For Prostate Cancer Awareness Month, Jeffrey Y.C. Wong, MD, discussed the evolving field of prostate cancer treatment and how it continues to improve.

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’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.

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.

A phase 3 clinical trial studying favezelimab in combination with pembrolizumab for the treatment of patients with previously treated PD–L1-positive metastatic colorectal cancer failed to meet its primary end point of overall survival.

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

Findings from the phase 3 SIERRA study showed that Iomab-B was associated with a higher durable complete response rate vs allogeneic cell transplant in older patients with relapsed/refractory acute myeloid leukemia.

Analysis of the TROPION-Breast01 study showed that treatment with Dato-DXd did not significantly improve overall survival compared with chemotherapy in HR-positive, HER2-low or -negative breast cancer.

Efficacy findings from the phase 2 AGAVE-201 support the use of axatilimab, which was approved by the FDA for recurrent or refractory chronic graft-vs-host disease in August 2024.

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.

Sangeetha Venugopal, MD, MS, discussed the evolving landscape of acute myeloid leukemia treatment as well as unmet needs among these patients.

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

Discover they major updates in oncology from the 2024 ESMO Congress, including featured breakthroughs from the leading experts.

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

Combining endocrine therapy with the dual HER2 blockade of trastuzumab and pertuzumab and the CDK4/6 inhibitor ribociclib showed potential as a novel approach for patients with HR+/HER2+ breast cancer.

Findings from the DESTINY-Gastric03 study support the further exploration of the antibody-drug conjugate trastuzumab deruxtecan for the first-line treatment of patients with advanced HER2+ gastric, esophageal, and GEJ cancers.

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

The phase 3 Shorespan-007 trial will compare bomedemstat with hydroxyurea in patients with treatment-naive essential thrombocythemia.

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

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

The trial previously met its primary end point of progression-free survival, and the final overall survival analysis was recently presented at the 2024 World Conference on Lung Cancer.

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

The bispecific T-cell engager tarlatamab showed continued efficacy and tolerable safety, according to follow-up from the phase 2 DeLLphi-301 study.

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