The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Approves Sacituzumab Govitecan for Pre-Treated HR+/HER2- Metastatic Breast Cancer
The approval is based on results from the phase 3 TROPiCS-02 trial demonstrating overall and progression survival benefits with sacituzumab govitecan compared with physician’s choice of single-agent chemotherapy.
FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a previous Bruton tyrosine kinase (BTK) inhibitor.
FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast Cancer
The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.
FDA Gives Zanubrutinib Approval for First-line, R/R CLL/SLL
The broad approval, while expected, will likely signal a milestone in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Tucatinib Plus Trastuzumab Approved for RAS Wild-type, HER2+ Unresectable or Metastatic CRC
The combination of tucatinib and trastuzumab received accelerated approval from the FDA to treat adults with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer (mCRC) that advances after treatment with specific types of chemotherapy.
Ublituximab Approved for Relapsing Forms of Multiple Sclerosis
Ublituximab-xiiy, developed by TG Therapeutics, will be sold under the name Briumvi.
FDA’s Lecanemab Approval Will Raise Pricing, Access Challenges, Says Dr Alvaro Pascual-Leone
The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School.
FDA Approves Lecanemab to Treat Early Alzheimer Disease
The lecanemab decision follows the controversial 2021 approval of aducanumab, which led to tight coverage restrictions for monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease.
FDA Approves Bispecific Antibody Mosunetuzumab for R/R Follicular Lymphoma
The approval makes mosunetuzumab the first in its class approved to treat follicular lymphoma and comes shortly after data from a phase 2 trial was presented at the annual meeting of the American Society of Hematology.
Dr Jessica Allegretti Explains Rebyota’s Mechanism of Action for the Prevention of Recurrent CDI
Jessica Allegretti, MD, MPH, medical director of the Crohn's and Colitis Center, Brigham and Women's Hospital, explained the mechanism of action for Rebyota, the first fecal transplant therapy approved by the FDA for the prevention of recurrent Clostridioides difficile infection (CDI) in individuals 18 years and older, following antibiotic treatment for recurrent CDI.
FDA Approves First Fecal Transplant Therapy for Prevention of CDI Recurrence
Ferring’s Rebyota, a novel first-in-class microbiota-based live biotherapeutic, has been approved by the FDA for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years and older, following antibiotic treatment for recurrent CDI.
Teplizumab Approved by FDA to Delay Type 1 Diabetes
The biologic is the first drug that aims to delay the diagnosis of type 1 diabetes.
FDA Approves Mirvetuximab Soravtansine-gynx for Platinum-Resistant Ovarian Cancer
In addition to the drug approval, the FDA approved a companion diagnostic to be used to identify patients who are eligible to receive the treatment.
FDA Approves Cemiplimab Plus Chemotherapy as First-line NSCLC Treatment
The FDA approved cemiplimab (Libtayo) in combination with platinum-based chemotherapy for the first-line treatment of advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations.
FDA Approves First Bispecific Antibody, Teclistamab, for R/R Multiple Myeloma
The FDA’s approval of teclistamab for relapsed/refractory (R/R) multiple myeloma makes it the first bispecific T-cell engager antibody to enter the treatment landscape.
Combination of Tremelimumab and Durvalumab Approved by FDA for Unresectable Liver Cancer
A dual immunotherapy option of tremelimumab, sold as Imjudo, in combination with durvalumab, sold as Imfinzi, was approved by the FDA Monday for the treatment of adult patients with unresectable hepatocellular carcinoma, the most common type of liver cancer.
Biosimilars, Orphan Drugs Headline Market Trends to Watch in Specialty Drug Pipeline
New and emerging medications in the specialty drug pipeline were discussed during a keynote address at AMCP Nexus 2022 by Aimee Tharaldson, PhD, senior clinical pharmacist of emerging therapeutics at Express Scripts, with biosimilars, orphan drugs, and cell and gene therapies emerging as key trends to watch.
Futibatinib Wins Accelerated FDA Approval in Cholangiocarcinoma
The targeted therapy, to be sold by Taiho Oncology as Lytgobi, had previously received breakthrough status in 2021 and was accepted for priority review in March.
bluebird bio Receives FDA Accelerated Approval for Rare Brain Disease Gene Therapy
The gene therapy is the first treatment for active cerebral adrenoleukodystrophy, a fatal neurodegenerative disease that affects boys.
Durvalumab With Chemo Wins FDA Approval in Treatment of Biliary Tract Cancers
An estimated 1 in 4 patients treated with durvalumab and chemotherapy (gemcitabine plus cisplatin) was alive at 2 years compared with 1 in 10 treated with chemotherapy alone, with these results contributing to the FDA's approval of the first immunotherapy to treat these cancers.
FDA Approves Pemigatinib for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
The FDA Friday approved pemigatinib (Pemazyre), a selective fibroblast growth factor (FGFR) inhibitor, to treat adults who have relapsed or refractory (R/R) myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement, a very rare and aggressive cancer.
FDA Approves First Gene Therapy for Beta-thalassemia
The FDA Wednesday approved betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.
FDA Approves Darolutamide Combo for Metastatic Hormone-Sensitive Prostate Cancer
Darolutamide, sold as Nubeqa, is an androgen receptor inhibitor, which works to limit prostate cell growth by preventing the binding of hormones, or androgens, to proteins known as androgen receptors.
Trastuzumab Deruxtecan Wins Rapid Approval for HER2-Low Breast Cancer
The approval came exactly 2 months after results from the landmark DESTINY-Breast04 trial showed that the antibody drug conjugate reduced the risk of disease progression or death by 50% compared with chemotherapy for HER2-low patients with both hormone receptor (HR)–positive and HR-negative disease.
FDA Approves Ruxolitinib Cream as First Repigmentation Therapy for Vitiligo
Ruxolitinib (Opzelura) cream is the first and only FDA-approved treatment for repigmentation in patients with vitiligo.
FDA Approves Pegloticase Injection Coadministered With Methotrexate for Gout
Pegloticase (Krystexxa) injection coadministered with methotrexate received FDA approval for the treatment of gout.
Dabrafenib Plus Trametinib Approved as First Tumor-Agnostic Therapy for BRAF V600E–Mutated Solid Tumors
The combination is the first and only therapy to be approved with a tumor-agnostic indication in both children and adults with solid tumors that have a BRAF V600E mutation, Novartis said late Wednesday.
FDA Approves Fifth Neulasta Biosimilar
The FDA approval for Fylnetra represents the fifth approval for a biosimilar referencing Neulasta (pegfilgrastim) in the United States.
FDA Approves Tisa-Cel for Third Indication, R/R Follicular Lymphoma
Tisagenlecleucel (tisa-cel) was approved to treat adults with relapsed or refractory (R/R) follicular lymphoma. This is the third indication for the therapy since it became the first FDA-approved chimeric antigen receptor T-cell therapy in 2017.
Nivolumab-Based Combos Approved in First-line Advanced ESCC
The approvals were announced by Bristol Myers Squibb (BMS), maker of the 2 immunotherapy treatments approved for 1 combination: nivolumab (Opdivo), the first approved PD-1 immune checkpoint inhibitor, and ipilimumab (Yervoy), which activates the immune system by targeting CTLA-4.
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