Oncology

Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.

Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.

While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.

Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.

This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.

There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.

Approved in May 2022, Tibsovo is the first therapy targeting cancer metabolism for older patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.

A Texas judge ruled that coverage for HIV pre-exposure prophylaxis (PrEP) violates religious freedom but there is concern that cancer screenings and other preventive services could be affected.

Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.

Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.

Prime Therapeutics’ predictive model was able to identify members with high breast cancer pharmacy and medical claims to help clients better manage drug spend.

Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.

A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.

Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.

Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.

More of these treatments have been approved, but supply chain issues and cost remain obstacles.

The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.

After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.

Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.

If approved, elacestrant would be the first oral selective estrogen receptor degrader (SERD) as a second- or third-line treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The PDUFA date is Feb. 17, 2023.

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.