Oncology

Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.

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.

Gavreto treats patients with advanced lung care and Arcalyst treats patients with recurrent pericarditis.

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

Talicia treats H. pylori infection, a risk factor for stomach cancer; Twirla is a hormonal contraceptive.

Tecartus is the first CAR T-cell therapy approved to treat adults with relapsed or refractory ALL.

Half of the 14 oncology indications approved in the second quarter were accelerated approvals.

This is the seventh approval for Erbitux and the only anti-EGFR antibody approved for this indication.

The PDUFA target action date for the FDA decision is Jan. 30, 2022.

The FDA assigned a Prescription Drug User Fee Act goal date of May 28, 2022.

Amgen’s Biosimilar Trend Report finds that biosimilars have been introduced at a price that is generally 15% to 37% lower than the reference product.

Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations.

This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.

Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.

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.

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

Real-world data show Erleada prolonged survival in both metastatic and non-metastatic castration-sensitive prostate cancer.

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.

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

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.

Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.

Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.

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.

The FDA has set a PDUFA date of December 23, 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.

The therapy is the first approved for patients with tumors associated with von Hippel-Lindau disease.