Oncology

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.

Welireg is now also indicated for patients whose renal cell carcinoma has progressed after treatment with PD-1 or PD-L1 inhibitor and a TKI therapy.

The FDA has set a target date of June 12, 2024, for tarlatamab to treat adult patients with advanced small cell lung cancer. If approved, it would be the first bispecific antibody for a solid tumor.

Augtyro, approved last month, launched with a month wholesale acquisition $29,000 for patients with ROS1-positive non-small cell lung cancer.

Shortages are growing because of disruption caused natural disasters and ingredient supply issues, as well as increased demand for certain drugs.

Jaypirca is also approved to treat mantle cell lymphoma. It has a list price of $21,000 for a 30-day supply.