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e-Newsletter : April 2020


April 2020

e-Newsletter

New Drug Approvals

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).

New Indications & Dosage Forms for Existing Drugs

Keytruda (pembrolizumab) for Injection New Dosage Regimen: April 28, 2020 Date of Original Approval: September 4, 2014

  1. 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:

  1. Mantle cell lymphoma (MCL) who have received at least one prior therapy.

  2. 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.

  3. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)

  4. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.

  5. Waldenström’s macroglobulinemia (WM).

  6. Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

  7. 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.

  8. 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:

  1. 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.

  2. 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:

  1. Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

  2. 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).

  3. Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Latest Generic Drug Approvals

  1. Albuterol Sulfate Metered Inhalation Aerosol 0.09mg base/inhalation Approved: April 8, 2020 – Cipla USA Inc. Generic for: Proventil HFA

  2. Clocortolone Pivalate Cream 0.1% Approved: April 22, 2020 – Taro Pharmaceuticals U.S.A., Inc. Generic for: Cloderm

#Approval #DrugInfo #Drugupdate #FDA

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