Oncology

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.

Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.

Janssen is seeking approval for use after Tagrisso in patients with metastatic non-small cell lung cancer.

A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.

Truqap is an AKT kinase inhibitor that, along with Faslodex, reduced the risk of disease progression or death by 50%.

Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

Augtyro will be available in mid-December to treat patients with metastatic ROS1-positive non-small cell lung cancer. It has a list price of $29,000 a month.

Aliqopa was granted accelerated approval in September 2017 to treat adult patients with relapsed follicular lymphoma.

Fruzaqla is the first inhibitor of all three VEGF receptor kinases. The list price is $25,200 for a 28-day supply of a 5 mg dose and $6,300 for a 28-day supply of 1 mg dose

The Choosing Wisely campaign has helped with overscreening and overtreatment. Some experts say better management of end-of-life care and value-based payment would also help steer oncology away from care with poor cost-benefit ratios.

The evidence for active surveillance is stronger, but advances in imaging have improved the ability to distinguish between indolent and aggressive forms of prostate cancer.

Loqtorzi is indicated in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy.

The mean lag time between FDA approval and insurance coverage for 89 cancer drugs ranged from 2.3 months to 8.2 months. But cancer drugs approved more recently were more likely to have shorter coverage lags.

N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.

Tibsovo is also approved to treat patients with IDH1-mutant acute myeloid leukemia and bile duct cancer.

The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.

Issues related to finding from an FDA inspection at a third-party filler have been resolved.

In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.

In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.

Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.