Oncology

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

ONC201 (dordaviprone) displayed “well tolerated and durable and clinically meaningful efficacy in Histone 3 (H3) K27M mutant-diffuse midline glioma DMG.”

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.

Research results reported in the journal Science today add to the evidence that “immunogenetics” likely influences people’s susceptibility to developing lung cancer, especially among smokers.

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.

A study published in Health Affairs shows that lung and colorectal cancer mortality was higher among veterans who were unhoused compared with those who were housed and higher yet in those who lost housing after they received a diagnosis.

The drugmaker is spending $15 million over a three-year period to address cancer care disparities in breast and prostate cancer.

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.

Leaders at City of Hope, a cancer research and care center in Los Angeles, forecast that in 2024 more people will benefit from cancer breakthroughs.

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.

Adherent patients accessed services only slightly more.

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.

Researchers developed a new multi-cancer blood screening test to detect early-stage cancers and found it had a high level of accuracy.

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.