Oncology

FDA Updates for the Week of October 11, 2021

October 16, 2021

In COVID-19 news: An advisory committee recommends both J&J's and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.

FDA Updates for the Week of Oct. 4, 2021

October 09, 2021

Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.

Oncology: Network Adequacy Rules for Cancer Care are Often Inadequate

October 07, 2021

Many states only have vaguely worded qualitative standards for network adequacy for cancer care. Others have quantitative standards based on distance or waiting time.

Study Suggests Berzosertib Does Not Benefit Metastatic Bladder Cancer Patients

September 22, 2021

A recent City of Hope study claims a therapy that combines a drug that disrupts DNA repair with chemotherapy cisplatin and gemcitabine does not prolong progression-free survival for patients with urothelial cancer.

Feasibility Study Shows Mobile Devices Help Patients Communicate Cancer Treatment Effects

August 31, 2021

Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.

FDA Updates: Genentech Withdraws Tecentriq Indication; New Approvals for Xarelto, Tibsovo

August 28, 2021

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

Financial Incentives Result in Small Increase in CRC Screening

August 25, 2021

Study results reported in JAMA Network Open show that financial incentives are only modestly effective in getting more people to get way screened for colorectal cancer.

FDA Updates: Opdivo, Jardiance and Jemperli Get Nods for New Indications

August 21, 2021

FDA approves Opdivo, Jardiance for new indication, Jemperli gets accelerated approval for solid tumors, and Lilly’s rapid-acting insulin, Lyumjev is approved for administration via an insulin pump.

Never Too Late To Quit: Smoking Cessation Pays Off for NSCLC Patients

July 26, 2021

Study shows that nonsmall cell lung cancer patients who smoke but quit after their diagnosis have better overall survival, progression-free survival than patients who continue to smoke.

FDA Updates: Merck’s Pneumococcal Vaccine Leads the Week

July 24, 2021

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.