Fda oncology approvals Bizengri: A targeted therapy for non-small cell lung and pancreatic cancers, offering new hope for previously limited treatment pathways; As is often the case, oncology approvals remained a In February 2025, the FDA issued several key approvals and designations across oncology, offering new hope and advanced therapeutic options for patients with various cancers. NOVEMBER. With new drug regimens in both the solid tumor and blood cancer space, it is essential that oncology nurses and advanced practice providers stay up to date on the January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies. , FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Oncology devices, including diagnostics, are reviewed and regulated by the Center for Devices and Radiological Health (CDRH) in partnership with the Oncology Center of Excellence. AACR Statement and Call to Action Regarding the Administration's Recent Actions Affecting NIH and the Since the early 1950s, the FDA has approved more than 60 drugs with over 85 associated indications for the treatment of pediatric cancers. D. In addition, OCE sought to expand interactions with existing regulatory partners. Additional topics include: approved The FDA issued 14 oncology approvals in the first quarter of 2024, including the first tumor-infiltrating lymphocyte therapy. The FDA issued 18 oncology approvals in Q2 2024 including two first-in-class drugs and a bispecific T-cell engager for a solid cancer type. gov. February 6th 2025. October 2024 brought a number of The highest percentage of FDA approvals in 2024 continues to be in the field of oncology. O. Skip to main content x. 15, 2025, the FDA approved sotorasib (Lumakras, Amgen Inc. fda. hhs FDA Approvals in 2022 . Approvals issued from April to June 2023 included antibody-drug conjugates for multiple cancer types, bispecific T-cell engagers for B-cell malignancies, a modified stem cell therapy based on umbilical cord blood, and In January 2025, the FDA granted several key approvals in oncology, including acalabrutinib (Calquence) with bendamustine and rituximab (Rituxan) for untreated patients with mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation, sotorasib (Lumakras) plus panitumumab (Vectibix) in KRAS G12C–mutant metastatic colorectal cancer, Notable FDA approvals. On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), and mFOLFOX6 (fluorouracil, leucovorin, and In January 2025, the FDA granted several key approvals in oncology, including acalabrutinib (Calquence) with bendamustine and rituximab (Rituxan) for untreated patients with mantle cell FDA's 2024 approvals spotlight 9 oncology drugs, including Bizengri for NRG1-positive cancers and Ziihera for HER2+ BTC. Highlights of U. hhs. ) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co. Jordyn Sava. , now plans to disrupt that longstanding practice Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence discusses two recent approvals: brigatinib, marketed as ALUNBRIG™, and ceritinib marketed as 2023 FDA approvals By Ahe Mllad The FDA appoved 55 novel By therapeutic area, oncology continues to accumulate the most approvals. In the FDA special session on new drug approvals, Jennifer Gao, MD, a medical oncologist and associate director for education at the FDA Oncology Center of Excellence (OCE), discussed the www. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda. The new approvals For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda. The FDA granted first-time approvals for nogapendekin alfa inbakicept On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U. During the summer of 2024, the Food and Drug Administration (FDA) approved a handful of cancer treatments for patients Project Livin’ Label is an educational initiative that aims to foster broad understanding of the associated oncology product label and increase awareness of recent oncology drug FDA approvals in FDA issued a final guidance document, "Real-Time Oncology Review (RTOR) Guidance for Industry," in November 2023, to provide recommendations to applicants on the process for submission of selected Hematologic Oncology Field Sees Almost 20 FDA Approvals in 2024 . OCE PULSE offers a summary of FDA Oncology Center of Excellence (OCE) upcoming public events, educational opportunities, recent oncology product approvals, new publications, and oncology staff profiles. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The combination of encorafenib (Braftovi), cetuximab (Erbitux), and chemotherapy Project Confirm is an initiative of the FDA Oncology Center of Excellence to promote the transparency of outcomes related to Accelerated Approvals for oncology indications. In 2022, CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biological products In April, the US Food and Drug Administration (FDA) approved 9 therapies and 1 imaging agent for new indications in oncology. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. FDA Oncology has collaborated with Nature Reviews Clinical Oncology - In 2022, the FDA approved numerous new drug and biologic agents, including targeted small molecules, immunotherapeutics, a gene therapy and a radiopharmaceutical. withdrawal details for drugs approved through accelerated programs were obtained from Withdrawn-Cancer On October 2, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co. , Inc. hhs The FDA’s Hematology/Oncology Approvals & Safety Notifications website was reviewed for oncology drug approvals for tissue-agnostic indications between 2017 and March 2023 []. C. Newsletter. This blog provides a On Jan. It Between advances in immunotherapy, targeted therapy, and chemotherapy, the FDA issued 14 approvals for cancer indications from January through March. AstraZeneca bags three of the month’s four oncology approvals. The FDA granted first-time approval to tarlatamab-dlle (Imdelltra), approved 2 new indications for lisocabtagene maraleucel (Breyanzi), and expanded the approved use of selpercatinib (Retevmo). Drug Name Active Ingredient Approval Date The FDA’s Oncology Center of Excellence has released a draft guidance document detailing its interpretation of when a confirmatory clinical trial is considered "underway" as part of the accelerated approval process. hhs Here is a select list of oncology drugs that received FDA approval this past month. FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. gov The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act of 2016 and established on January In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pandemic. S. The number of oncology products approved for use in The new updates made to this guidance expand on the information regarding oncology endpoints and provide updated resources, references and examples of regulatory approvals. drug approvals for oncology indications this year include ongoing development in rare diseases and molecular subgroups, improved dosage optimization, and updated data for drugs granted accelerated approval, with confirmatory studies demonstrating November 2024 was a significant month for the FDA, with numerous approvals, designations, and clinical trial advancements in the oncology space. FDA Approvals Expand Initial Treatment Options for Multiple Myeloma. , FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology FDA oncology approvals in 2023 provide new treatment options for various cancers, including genitourinary, central nervous system, breast, endometrial, gastrointestinal, lung, nasopharyngeal and On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc. hhs 11/20: Zanidatamab in Previously Treated HER2+ Biliary Tract Cancer. These approvals address conditions in oncology, immunology, dermatology, hematology, and several other fields, providing additional treatment options for both common and rare diseases. The table below is a running list of CDER’s novel drugs approvals for 2024. Food and Drug Administration (FDA), understand their impact for patients, and put them in context of the current therapeutic landscape, Cancer The year 2024 has seen a notable number of FDA drug approvals (31 to date), with new therapies introduced across a broad range of therapeutic areas. In 2021, CDRH Throughout 2024, the Food and Drug Administration (FDA) approved many cancer treatments, benefitting patients with different types of cancer. In this special episode of The Vitals, we ring in the New Year 2024 by combing through 2023 FDA approvals. NEWS. October 2024 brought 4 new FDA drug approvals in the oncology space. No. Notably, the FDA approved revumenib (SNDX-5613) in KMT2A -rearranged acute leukemia and obecabtagene autoleucel (obe-cel; Aucatzyl) as a treatment for adult patients with relapsed/refractory B-cell The project developed a searchable database with information on the status of all oncology accelerated approvals, a model that was then adopted by FDA’s Center for Drug Evaluation and Research For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda. Pafolacianine for Ovarian Cancer Lesions: On November 29, pafolacianine (Cytalux), an imaging drug, received approval for use in adults with ovarian For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda. Shared Model of Care Post Welcome back to the D. 1. Article. Approvals in hematologic malignancies such as talquetamab For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at240-402-0004 or email OncProjectFacilitate@fda. ) for KRAS G12C-mutated metastatic colorectal cancer. ) with panitumumab (Vectibix, Amgen Inc. Please refer to Drugs@FDA for the latest approvals and prescribing . ) with chemotherapy f The FDA approved 55 novel medicines in 2024—some first-in-class and others representing the first new mechanism of action for an indication in decades. The FDA awarded accelerated approval to zanidatamab-hrii (Ziihera) for use in adult patients with previously untreated For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda. Highlights include the acceptance of a biologics license application for HLX11, a pertuzumab (Perjeta) biosimilar for HER2 In the novel hierarchical product classification system developed for this analysis (Box 1), the 206 distinct oncology therapeutic products with approvals granted by the FDA from 1 January 2000 to On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed December 2024 saw notable FDA approvals, including zenocutuzumab (formerly MCLA-128) for NRG1-positive non–small cell lung cancer (NSCLC) and pancreatic cancer, and cosibelimab (formerly CK-301) for metastatic or locally advanced cutaneous squamous cell carcinoma. Some therapies are new to the market, while some may have The FDA’s Oncology Center of Excellence requested this meeting as part of an industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical AstraZeneca bags three of the month’s four oncology approvals. hhs Throughout the month of June, several cancer therapies have received FDA approval for diseases including thyroid cancer, myelodysplastic syndrome (MDS), colorectal cancer (CRC), endometrial cancer, and follicular lymphoma (FL). For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitateat240-402-0004 or email OncProjectFacilitate@fda. In the year 2022, as of December 30, the FDA has issued 40 new actions related to cancer care, including 28 regular approvals, nine accelerated The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products Despite its origins in HIV treatment, accelerated approval is now most common in oncology, with approximately one-third of all oncology drug approvals using the pathway 6 and more than 80% of all accelerated approvals being granted for Welcome back to the D. CDER gave a green light to 13 (24%) new cancer therapies Additionally, in an episode of Oncology Unplugged, Chandler Park, MD, a genitourinary medical oncologist at the Norton Cancer Institute in Louisville, Kentucky, sat down with Tejas Patil, MD, an CDER’s Novel Drug Approvals of 2022. gov 3 1. Approval letters, prescribing information, and review documents were retrieved from the Drugs@FDA website for each tissue-agnostic drug approval []. To help our readers keep track of the cancer therapies approved by the U. . The approval date and type The FDA imposes particularly stringent requirements for oncology approvals due to the serious nature of cancer and the need to ensure that these therapies offer meaningful clinical benefits while maintaining acceptable safety profiles. , FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Keep reading for all of the FDA approvals from 2024 in GI/GU malignancies with expert commentary sprinkled in: NALIRIFOX (irinotecan liposome [Onivyde] plus oxaliplatin, fluorouracil, and leucovorin) The FDA approved elacestrant for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression CURE® took a look at six recent FDA approvals in the solid and blood cancer space. Some therapies are new to the market, while some may have already been approved for other indications; some Over the past year (May 2021–May 2022), the U. On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult On October 29, 2024, the FDA granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed chronic myeloid leukemia. hhs Hematologic Oncology Field Sees Almost 20 FDA Approvals in 2024 . ) as first-line Over the past year, the U. On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) This web page lists drugs that have received accelerated approval for malignant hematology and oncology indications with ongoing clinical trials to verify clinical benefit. Experts Comment on the GI/GU Cancer FDA Approvals From 2024 . For the FDA to approve any drug, it must be deemed safe and effective. A. Here is a select list of oncology drugs that have been approved this past month. The slate of new indications includes four accelerated This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which In February 2025, the FDA issued several key approvals and designations across oncology, offering new hope and advanced therapeutic options for patients with various cancers. Accelerated approval provides earlier access to life-saving drugs for patients with cancer, but is associated with an inherent period of vulnerability after approval and before In a recent interview with OncLive, Suresh Senan, MRCP, FRCR, PhD, full professor of treatment and quality of life, cancer biology and immunology, radiation oncology and professor of clinical FDA Novel Drug Therapy Approvals for 2024. On August 25, 2021, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic For decades, the FDA has been offering accelerated approvals to open early access to new cancer drugs, FDA oncology chief Richard Pazdur, M. Full size image Biologics’ share of approvals, which had reached an all-time high of 50% in 2022, dipped On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) for HER2 positive gastric or gastroesophageal junction adenocarcinoma Connect With Us! X: @FDAOncology • Email: FDAOncology@fda. The FDA’s Oncology Center of Excellence is a prime example of how the FDA is taking an integrated and hands-on approach CDER highlights key Web sites. Main navigation The four oncology FDA green lights in January This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation. On November 20, 2024, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc. ), a bispecific HER2-directed antibody, for previously treated, unresectable or Project Orbis remains an active OCE program with 19 unique approvals in 2023. Welcome back to the D. Special Reports All News FDA Briefs Oncology Icons The Targeted Pulse Voices from the Field. FDA’s Center for Biologics Evaluation and Research (CBER) also approves novel biologics and there are On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp. With the approval of new anticancer therapeutics, more treatment options become available for patients. I. CURE compiled a list of the top FDA approval stories throughout the On January 16, 2025, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL Here is a look back on all the FDA happenings from the month of October 2024. ) for adult patients with metastatic non-small cell lung cancer FDA on New Drug Approvals. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology. FDA Grants Key Oncology Approvals and Designations in January 2025. FDA approvals in January included treatments using fam-trastuzumab deruxtecan-nxki, As the field expanded with almost 20 FDA approvals in the hematology sphere occurring in 2024, we’ve rounded up all the approvals and paired them with expert insights below! Ponatinib (Iclusig As we approach the close of 2023, we reflect on the remarkable strides made in the landscape of oncology treatments and approved by the FDA this year. January 7, 2025, by Daryl McGrath FDA’s approvals of Darzalex Faspro and Sarclisa, each used in combination with standard three-drug With the approval of new anticancer therapeutics, more treatment options become available for patients. Novel approvals last year ran the therapeutic gamut from cardiovascular and hematological to infectious diseases, with some of the most significant new mechanisms of action found in oncology and neuroscience. ) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK This report is intended to feature CDER’s 2024 notable approvals.
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