Formulary Watch |

FDA Approves Breyanzi for Mantle Cell Lymphoma

Breyanzi is a CAR T-cell therapy now approved for four subtypes of non-Hodgkin lymphoma.

FDA Approves Non-Stimulant ADHD Medication

FDA Sets Date for Zanidatamab in Bile Duct Cancer

Zanidatamab is bispecific antibody that targets HER2 in patients with metastatic biliary tract cancer. The FDA has set an action date of Nov. 29, 2024.

FDA Assigns Review Date for Inavolisib in Metastatic Breast Cancer

The FDA has set a Prescription Drug User Fee Act date of Nov. 27, 2024, to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer.

FDA Approves First Interchangeable Biosimilar of Soliris

Bkemv is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.

Global Spending on Cancer Drugs to Increase to $409 Billion

Verastem Begins Submission for Ovarian Cancer Combination

Verastem is studying the combination of avutometinib and defactinib to treat low-grade serous ovarian cancer in patients with KRAS-mutations. The company plans to complete the new drug application in the second half of this year.

Updated: FDA Approves First Interchangeable Biosimilars to Eylea

Optum Rx to Offer Guarantee-Based Pricing Model

Atara Submits BLA for Cell Therapy for Post-Transplant Complication

If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease.

FDA Approves Bispecific Antibody for Small Cell Lung Cancer

Tarlatamab — now with the brand name Imdelltra — is the first approved bispecific antibody for a solid tumor.

FDA Approves Breyanzi for Follicular Lymphoma

Breyanzi is now included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a recommendation for third-line therapy for relapsed or refractory follicular lymphoma.

Biogen, Eisai Begin Submission of Subcutaneous Leqembi

If approved, the Leqembi autoinjector could be used to administer the treatment for Alzheimer’s disease at home or at medical facilities.

FDA Sets Review Date for Gene Therapy for Enzyme Deficiency

Boehringer Ingelheim is Second Company to Provide Private-Label Humira Biosimilar to Evernorth

Boehringer Ingelheim also received FDA approval for a high-concentration formulation of Cyltezo, its branded Humira biosimilar.

Administrative Issues Delay FDA Decision on Moderna RSV Vaccine

Regulators are now working to complete their review of the BLA for mRNA-1345 by the end of May 2024. mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices in June 2024.

KFF: 1 in 8 Adults have Used GLP-1 Agonists

Orladeyo Can Reduce Health Resource Use in HAE

Investigational Anticoagulant May be Cost-Effective

FDA Sets Date for Advisory Committee Meeting for Midomafetamine for PTSD

If approved, midomafetamine would be the first psychedelic-assisted therapy approved for any mental health condition. The advisory committee meeting is June 4, 2024.

FDA Accepts BLA for Pancreatic and Lung Cancer Therapy

Zenocutuzumab is a new type of bispecific antibody that target both HER2 and HER3 proteins to inhibit NRG1 binding and blocking the mechanism for tumor survival. The FDA’s target date is in December 2024.

FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease

The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday, June 10, 2024, to discuss the phase 3 trial of Lilly’s donanemab to treat patients with early symptomatic Alzheimer’s disease.

IQVIA: Medicine Spending Expected to Grow 4% to 7% by 2028

FDA Approves Liquid Mycophenolate to Prevent Organ Rejections

Myhibbin is a ready-to-use mycophenolate mofetil oral suspension to prevent rejection of kidney, heart and liver transplants.

FDA Assigns Action Date for Subcutaneous Opdivo

Survey: Managing Total of Cost of Care is Top Priority

Alvotech to Manufacture Interchangeable Humira Biosimilar for Teva and Quallent

FDA Converts Tivdak’s Accelerated Approval to Full Approval for Cervical Cancer

A phase 3 trials showed Tivdak demonstrated a 30% reduction in the risk of death. The U.S. list price is $6,599 per 40 mg single dose vial.

What We're Reading: More on Cigna’s Reviews of Claims

Express Scripts Adds Zymfentra to National Preferred Formulary