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FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 102
- January 26, 2024
Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
- Source: drugdu
- 86
- January 26, 2024
Announcement on the Acceptance of Application for Clinical Trial of 20-valent Pneumococcal Polysaccharide Conjugate Vaccine

Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
- Source: drugdu
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- January 26, 2024
INNOCARE Pharmaceutical Co., Ltd. voluntarily discloses the announcement on the progress of ICP-723 clinical trial

INNOCARE Pharmaceuticals Limited (the “Company” or “INNOCARE”) is currently in the clinical phase of registration of its innovative drug zurletrectinib (ICP-723). zurletrectinib (ICP-723) has shown favorable safety and efficacy in adult and adolescent (12 to 18 years old) patients. zurletrectinib (ICP-723) has demonstrated a favorable safety and efficacy profile in adults and adolescents (12 to 18 years of age), and has recently completed the first case of administration in a pediatric patient (2 to 12 years of age), initiating the first clinical study in a pediatric patient. The main information is announced as follows: I. Introduction of ICP-723 Zurletrectinib (ICP-723) is INNOCARE’s proprietary second-generation pan TRK small molecule inhibitor for the treatment of patients with advanced or metastatic solid tumors harboring NTRK fusion genes who have not received TRK inhibitor therapy and who are resistant to first-generation TRK inhibitors. Zurletrectinib (ICP-723) can effectively inhibit not only TRKA, TRKB, and TRKC ...
- Source: drugdu
- 83
- January 26, 2024
Grand Pharma Strategically Controls Duoputai Pharmaceutical Technology, Strengthening the Strategic Plan in Field of Cerebro-cardiovascular Disease Treatment

Xi’an Beilin Pharmaceutical Co., Ltd. (西安碑林药业股份有限公司, Xi’an Beilin), a subsidiary of Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK), recently entered into the second acquisition agreement with Chongqing Duoputai Pharmaceutical Co., Ltd. (重庆多普泰制药股份有限公司). Xi’an Beilin is to acquire 63% equity interest in Chongqing Duoputai Pharmaceutical Technology Co., Ltd. (重庆多普泰医药科技有限公司, Duoputai Pharmaceutical Technology) at a consideration of RMB442.26 million following the fulfillment of the relevant conditions. With the completion of the acquisition agreement, Xi’an Beilin will hold a 90% equity interest in Duoputai Pharmaceutical Technology, which will become a subsidiary of Grand Pharma to further consolidate the Group’s market position in the field of cerebro-cardiovascular disease treatment. https://www.grandpharm.com/en/news/grand-pharma-strategically-controls-duoputai-pharmaceutical-technology-strengthening-the-strategic-plan-in-field-of-cerebro-cardiovascular-disease-treatment
- Source: drugdu
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- January 26, 2024
Major update of the SME user guide

The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development, and has become a reference source of information for SME and academic developers, supporting them to navigate the system of medicine regulation in the EU. The new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines: Veterinary Regulation: the document has been fully revised to align with the veterinary regulation Clinical Trials Regulation (new section 4.4): provides an overview of the clinical trial regulation and Clinical Trials Information System (CTIS) Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines Other important new sections/subsections include: IT Systems (section 1.3): An overview of common platforms, systems, and databases ...
- Source: drugdu
- 86
- January 26, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
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- January 26, 2024
Reuters

Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters. In all last year, the AAPCC revealed that there were 3,316 calls from users of semglutide, the active ingredient in Ozempic. It was more than double the number of calls from the previous year and a 15-fold increase from 2019, according to CNN. Most of the calls were for severe episodes of the commonly known side effects of semaglutide, which include nausea, vomiting and stomach pain. Most cases were resolved with intravenous fluids and nausea medications. Of the three dangerous U.S. cases of low blood sugar, also known as hypoglycemia, the AAPCC suspected the users were supplied with fake versions of semaglutide. All three cases were reported from the same regional poison control center, of which there are 55 ...
- Source: drugdu
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- January 26, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
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- January 25, 2024
Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
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- January 25, 2024

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