Visual MD
May 1, 20204 min
April 2020
e-Newsletter
Ongentys (opicapone) Capsules
Company: Neurocrine Biosciences, Inc.
Date of Approval: April 24, 2020
Treatment for: Parkinson’s Disease
Ongentys (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) Injection
Company: Sanofi
Date of Approval: April 23, 2020
Treatment for: Meningococcal Meningitis Prophylaxis
MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) is a MenACWY vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 2 years of age and older.
Trodelvy (sacituzumab govitecan-hziy) Injection
Company: Immunomedics, Inc.
Date of Approval: April 22, 2020
Treatment for: Breast Cancer
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate for the treatment of patients with previously-treated metastatic triple-negative breast cancer (mTNBC).
Tukysa (tucatinib) Tablets
Company: Seattle Genetics, Inc.
Date of Approval: April 17, 2020
Treatment for: Breast Cancer
Tukysa (tucatinib) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer.
Pemazyre (pemigatinib) Tablets
Company: Incyte Corporation
Date of Approval: April 17, 2020
Treatment for: Cholangiocarcinoma
Pemazyre (pemigatinib) is a selective fibroblast growth factor receptor (FGFR) inhibitor for the treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, as detected by an FDA-approved test.
Emerphed (ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals, Inc.
Date of Approval: April 17, 2020
Treatment for: Hypotension
Emerphed (ephedrine sulfate) is a ready-to-use formulation of the approved pressor agent ephedrine indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Jelmyto (mitomycin) for Pyelocalyceal Solution
Company: UroGen Pharma Ltd.
Date of Approval: April 15, 2020
Treatment for: Urothelial Carcinoma
Jelmyto (mitomycin) is a novel formulation of the approved alkylating drug mitomycin for the treatment of patients with low-grade upper tract urothelial cancer (LG-UTUC).
Koselugo (selumetinib) Capsules
Company: AstraZeneca and Merck
Date of Approval: April 10, 2020
Treatment for: Neurofibromatosis Type 1
Koselugo (selumetinib) is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Sevenfact (coagulation factor VIIa (recombinant)-jncw) Injection
Company: HEMA Biologics, LLC
Date of Approval: April 1, 2020
Treatment for: Hemophilia A or B with Inhibitors
Sevenfact (coagulation factor VIIa [recombinant]-jncw) is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).
Keytruda (pembrolizumab) for Injection
New Dosage Regimen: April 28, 2020
Date of Original Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.
Imbruvica (ibrutinib) Capsules and Tablets
New Indication Approved: April 21, 2020
Date of Original Approval: November 13, 2013
Imbruvica (ibrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with:
Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
Waldenström’s macroglobulinemia (WM).
Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
Braftovi (encorafenib) Capsules
New Indication Approved: April 8, 2020
Date of Original Approval: June 27, 2018
Braftovi (encorafenib) is a kinase inhibitor indicated:
in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Reblozyl (luspatercept-aamt) for Injection
New Indication Approved: April 3, 2020
Date of Original Approval: November 8, 2019
Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for the treatment of:
Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Albuterol Sulfate Metered Inhalation Aerosol 0.09mg base/inhalation
Approved: April 8, 2020 – Cipla USA Inc.
Generic for: Proventil HFA
Clocortolone Pivalate Cream 0.1%
Approved: April 22, 2020 – Taro Pharmaceuticals U.S.A., Inc.
Generic for: Cloderm