April 2021 New Drug Approvals
Qelbree: Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. (1)
Nextstellis: is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.(2)
Axum Rx offers a drug pipeline management solution across pharmacy and medical benefit. With Axum Rx’s pipeline management solution, you can anticipate and mitigate the impact of the drug pipeline on your bottom line today!
Jemperli: is a programmed death receptor-1 (PD-1)–blocking antibody permanently discontinue JEMPERLI based on severity of reaction. Indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with Complications of allogeneic HSCT after PD-1/L-1–blocking antibody: a platinum-containing regimen. (3) Follow patients closely for evidence of transplant-related complications and intervene promptly. (3)
This indication is approved under accelerated approval based on tumor Embryo-fetal toxicity: Can cause fetal harm. Advise females of response rate and durability of response. Continued approval for this reproductive potential of the potential risk to a fetus and to use effective indication may be contingent upon verification and description of clinical contraception benefit in a confirmatory trial(s). (3)
Zynlonta: is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. (4)
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (4)