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FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
- Source: drugdu
- 100
- December 4, 2023
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

By Tristan Manalac Pictured: Sign outside the FDA’s office in Maryland The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India. The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination. In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with ...
- Source: drugdu
- 112
- December 2, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date ...
- Source: drugdu
- 133
- December 2, 2023
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea

Dive Brief Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the green light to an application that was previously only possible off-label. The company’s trio of devices, called Complete Airway Repositioning and/or Expansion (CARE) oral appliances, include the DNA, mRNA and mmRNA products. Vivos’ share price increased nearly 834% to $41 when the market closed on Wednesday. The medtech company’s market capitalization was approximately $30.8 million even after the latest jump in its stock, according to Nasdaq. Dive Insight Vivos sells a set of airway repositioning and expansion devices for treating dentofacial abnormalities and OSA. The company has worked to add clearances to use more of the devices in the treatment of OSA, winning a ...
- Source: drugdu
- 92
- December 2, 2023
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug

Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
- Source: drugdu
- 100
- December 1, 2023
Intas on import alert as FDA flags data manipulation, management failures in warning letter

Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency. After a May inspection of Intas’ plant in Gujarat, India, the FDA published a warning letter that points a finger at management and labels products made at the site “adulterated” because of the company’s manufacturing deficiencies. Before this development, the FDA earlier this year slapped the site with a Form 483 filing outlining problems at the plant. Shortly after that, the company provided a response that proved to be “inadequate,” as the FDA described it. In the warning letter, the FDA blasted Intas for an “egregious pattern” of shortfalls that shows the company’s failure to carry out “basic responsibilities.” The agency tracked multiple instances of data manipulation going back to 2021. In these cases, visual inspectors manipulated particle and other ...
- Source: drugdu
- 100
- December 1, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 96
- December 1, 2023
FDA Launches Probe of Malignancies Linked to CAR-T Therapies

By Tyler Patchen Pictured: Exterior of an FDA building/iStock, Grandbrothers The FDA announced Tuesday that it is investigating the “serious risk” of malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The regulator said it has determined that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies” including Bristol Myers Squibb’s Abcema and Breyanzi, Johnson & Johnson’s Carvykti, Novartis’ Kymriah and Gilead’s Tecartus and Yescarta. “T-cell malignancies have occurred in patients treated with several products in the class,” according to the FDA, which said it received reports from clinical trials and postmarketing adverse event data. While the agency said that the overall benefits of these products continue to outweigh their potential risks, it “is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the ...
- Source: drugdu
- 112
- November 30, 2023
FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
- 225
- November 30, 2023
FDA withdraws from Global Harmonization Working Party

Dive Brief The U.S. Food and Drug Administration decided to withdraw from the Global Harmonization Working Party (GHWP), one of multiple groups working to align international standards for medical devices. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, raised concerns about “divergent harmonization efforts” in a Monday letter to Jinghe Xu, chair of the GHWP and deputy commissioner of China’s National Medical Products Administration. Shuren’s concerns included efforts that do not align with the FDA’s priorities or international best practices and the lack of collaboration with the International Medical Device Regulators Forum (IMDRF), another international standards group. Dive Insight The FDA joined the GHWP in December 2021 with the goal of serving as a bridge between the organization and the IMDRF. At the time, the FDA didn’t realize how divergent the two organizations had become, Shuren wrote. “I would like to see GHWP and IMDRF collaborating ...
- Source: drugdu
- 221
- November 29, 2023

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