Oncology

Ojemda will have a wholesale acquisition cost of $33,916 for a 28 day supply and will be distributed through specialty pharmacies Biologics by McKesson and Onco360.

Lutathera is a radiotherapeutic that is now approved for patients 12 years and older neuroendocrine tumors in the pancreas or gastrointestinal tract.

ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.

The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.

FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.

The full approval was based on the confirmatory phase 3 MIRASOL trial, which showed that Elahere resulted in a 33% reduction in risk of death and a 35% reduction in the risk of cancer progression.

The accelerated approval of Iclusig for patients with acute lymphoblastic leukemia and with the Philadelphia chromosome was based on a surrogate endpoint. Iclusig has a list price of $20,831 for 30 tablets.

The FDA has assigned a goal date of Aug.13, 2024, for Lymphir to treat patients with relapsed or refractory cutaneous T-cell lymphoma.

Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

Breyanzi is the first CAR-T therapy to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Both Wyost and Jubbonti are interchangeable for the reference products and are approved for all of the same indications

Rybrevant is indicated to be used in combination with chemotherapy as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.

The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.

Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.

Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.

Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024

If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.

Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.

Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.

Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

The Oncologic Drugs Advisory Committee will meet on March 15, 2024, to review overall survival data for Abecma in earlier lines of treatment in relapsed or refractory multiple myeloma.

Bristol Myers Squibb is seeking approval of Breyanzi, a CD19-directed CAR T-cell therapy, to treat patients with follicular lymphoma and mantle cell lymphoma.

The FDA orders new warnings for CAR-T cell therapies due to reports of T-cell malignancies, including fatal cases, applying to BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.

Balversa targets FGFR3 genetic alterations and is approved as a second-line treatment for in adult patients with metastatic urothelial carcinoma.

Adstiladrin delivers a gene that encodes for the interferon alpha-2b protein, and it provides an option for those at high risk of recurrence and metastatic bladder cancer.

Tivdak was granted accelerated approval in September 2021 to treat patients with recurrent or metastatic cervical cancer. The goal date for full approval is May 9, 2024.

The FDA cited issues with a third-party manufacturing company. Zolbetuximab is being reviewed to treat patients with stomach cancer.

Loqtorzi has a wholesale acquisition cost of $8,892.03 per single-use vial.

Additionally, the FDA has approved Avzivi — the fifth biosimilar that references the cancer drug Avastin.