Last month, the US Food and Drug Administration (FDA) approved two new drugs, expanded the indications for several other agents as well as a diagnostic test, and issued a clinical trial hold on a trial investigating a new immunotherapy agent.
Here’s a snapshot of what happened in January.
New Drugs
1. The FDA has approved datopotamab deruxtecan (Datroway) to treat certain patients with unresectable or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. This approval for datopotamab deruxtecan — discovered by Daiichi Sankyo and jointly developed with AstraZeneca — was based on findings from the open-label TROPION-Breast01 trial, in which patients were randomized 1:1 to receive datopotamab deruxtecan or the investigator’s choice of chemotherapy (mostly eribulin, but also capecitabine, vinorelbine, or gemcitabine). Median overall survival did not differ significantly between the two arms, but median progression-free survival was significantly longer in the treatment arm at 6.9 months vs 4.9 months in the chemotherapy arm (hazard ratio [HR], 0.63).
2. The FDA has approved treosulfan (Grafapex, Medexus Pharmaceuticals) alongside fludarabine as a preparative regimen to clear bone marrow before allogeneic hematopoietic stem cell transplant in adults and children with acute myeloid leukemia or myelodysplastic syndromes at a greater risk for adverse events from standard conditioning regimens. Approval was based on results from a phase 3 trial, which reported a 36-month overall survival rate of 66.8% among patients who received treosulfan vs 56.3% among those who received busulfan (HR, 0.64; P = .0037).
New or Expanded Indications
1. The FDA has approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for certain adult patients with metastatic colorectal cancer (CRC). More specifically, the combination is indicated for patients with KRAS G12C–mutated metastatic CRC who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Approval was based on findings from the CodeBreaK 300 trial, which evaluated sotorasib plus panitumumab vs the investigator’s choice of trifluridine/tipiracil or regorafenib. While overall survival between the treatment arms was not significantly different, patients receiving sotorasib plus panitumumab did demonstrate significantly better progression-free survival (5.6 months vs 2 months; HR, 0.48) and a better overall response rate (26% vs 0%).
2. The FDA has approved acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. Approval was based on findings from the phase 3, randomized, placebo-controlled ECHO trial, which reported improved progression-free survival with the treatment combination vs placebo plus bendamustine and rituximab (median of 66.4 vs 49.6 months; HR, 0.73). In the ECHO trial, serious adverse reactions occurred in 69% of patients receiving acalabrutinib plus bendamustine and rituximab, and fatal adverse reactions occurred in 12%.
The FDA also granted full approval, following an accelerated approval in 2017, for acalabrutinib in patients with previously treated MCL.
3. The FDA has approved trastuzumab deruxtecan (Enhertu, AstraZeneca and Daiichi Sankyo) for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer that has progressed after one or more endocrine therapies. The expanded approval allows for the drug’s use in an earlier setting, thereby expanding the patient population eligible for treatment, according to an AstraZeneca press release.
Approval was based on findings from the phase 3 DESTINY-Breast06 trial, which showed that among the patients with HER2-low disease, the median progression-free survival was 13.2 months in the trastuzumab deruxtecan group vs 8.1 months in the chemotherapy group (HR for disease progression or death, 0.62). The researchers reported a similar progression-free survival benefit in the exploratory HER2-ultralow population.
4. The FDA has approved a new generic version of everolimus tablets for oral suspension (Afinitor Disperz, Amneal), according to a company press release. Everolimus tablets are available from many generics companies and carry indications for renal, breast, and neuroendocrine tumors as well as tuberous sclerosis complex. However, everolimus tablets for oral suspension, which are meant to be dissolved in water for patients who have difficulty swallowing pills, are indicated only for tuberous sclerosis complex–associated subependymal giant cell astrocytoma in adult and pediatric patients aged ≥ 1 year. The original Novartis product carries the same indication as well as an indication for adult and pediatric patients aged ≥ 2 years with tuberous sclerosis complex–associated partial-onset seizures.
The new generic, which is available in 2, 3, and 5 mg, joins a generic version of the oral suspension tablets already on the market from Mylan/Viatris. The approval “increases the supply of an oncology product that has limited suppliers,” Amneal said in its press release.
5. The FDA has approved FoundationOne CDx (Foundation Medicine, Inc) for use as a companion diagnostic for the glioma drug, tovorafenib (Ojemda). Tovorafenib was approved last year for patients aged ≥ 6 months with relapsed/refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation. FoundationOne CDx has already been approved as a companion test for multiple cancer drugs, including agents for lung cancer and breast cancer.
This “tissue-based companion diagnostic test is uniquely capable of detecting both BRAF V600 mutations and fusions, which enables providers to gain the complete genomic picture of their patient’s tumor and guide treatment decision making,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, Cambridge, Massachusetts, said in a company press release.
Declined Approval/Clinical Trial Hold
The FDA has placed a clinical trial hold on trials evaluating the investigational immunotherapy agents tabelecleucel (tab-cel) and ATA3219, according to statements from drugmaker Atara Biotherapeutics.
The FDA also declined to approve tabelecleucel, which has been under FDA review as a monotherapy for adult and pediatric patients aged ≥ 2 years with Epstein-Barr virus–positive post-transplant lymphoproliferative disease after at least one prior therapy, including an anti-CD20–containing regimen.
ATA3219 is being developed to treat non-Hodgkin’s lymphoma and systemic lupus erythematosus.
In mid-January, the FDA issued a complete response letter to Atara for tabelecleucel, citing manufacturing issues at a third-party manufacturing facility, according to a company press release.The clinical trial hold also applies to ATA3219 because the starting materials used in its production are sourced from the same third-party facility producing tabelecleucel, according to a subsequent statement from Atara.
The problems were found during a routine FDA prelicensing inspection. The company said the concerns were not related to safety or efficacy issues, and the FDA has not asked for additional studies. Atara said it plans to resubmit the tabelecleucel application after the issues are resolved.
Source link : https://www.medscape.com/viewarticle/last-month-oncology-fda-cancer-news-roundup-2025a10002qb?src=rss
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Publish date : 2025-02-04 13:15:01
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