Oncology

Tecentriq is the first cancer immunotherapy available for adjuvant treatment of non-small cell lung cancer (NSCLC).

Dr. Reddy’s received FDA approval for two strengths of lenalidomide for the treatment of patients with multiple myeloma.

Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.

This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.

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

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

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.

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.

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.

The FDA has set a PDUFA date of December 23, 2021.

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

The therapy is expected to be available by early September.

Libtayo also reduced the risk of death by 29% compared with chemotherapy alone.

The graft-versus-host disease therapy has also been added to NCCN Guidelines.