Oncology

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.

Developing novel drugs to treat cancer remains a strong focus for drug developers. Several first-in-class therapies have become available over the last few months.

Momelotinib — now with the brand name Ojjaara — is the first treatment for myelofibrosis patients with anemia. It has a list price of $26,900 for a bottle of 30 tablets.

The date has been extended by three months to Feb. 24, 2024, because of resource constraints at the regulatory agency.

In clinical trials, Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal to enable stem cell transplantation for patients with multiple myeloma. It will have a list price 5,900 per vial, with most patients needing two vials for treatment.

In a 10-year, follow-up study in patients vaccinated with Gardasil 9, no cases of HPV-related cancers or genital warts were seen.

In head-to-head study, Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion independence and hemoglobin increase vs. epoetin alfa.

The FDA granted accelerated approval to Balversa in 2019. Patients who received Balversa in Janssen’s confirmatory study achieved a median overall survival of more than one year. It reduced the risk of death by 36%.

If approved, Xtandi would be the first hormonal therapy for non-metastatic patients with increasing PSA levels. The FDA has assigned an action date in the quarter of 2023.

The FDA set an action date of June 16, 2024, for imetelstat to treat transfusion-dependent anemia in myelodysplastic syndromes. Regulators said they plan to hold an advisory committee meeting as part of their review.

Tibsovo is currently approved in the United States as a monotherapy to treat adults with IDH1-mutant relapsed or refractory acute myeloid leukemia.

Elrexfio is a bispecific antibody to treat relapsed or refractory multiple myeloma. It will be available within the next few weeks and have a monthly list price of $41,500.

The combination of niraparib and abiraterone in a single tablet — now with the name Akeega — will be available in mid-September and have a list price of $18,750 for a 30-day supply.

Talvey is a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It will available in a few weeks and have a price of $45,000 per month.

Avasopasem was under review to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The FDA has indicted that an additional trial would be needed to show safety and effectiveness of avasopasem.

This abstract at the American Society of Clinical Oncology (ASCO 2023) looked at the growing utilization of trastuzumab biosimilars over time in India.