MCQ: Recent FDA approvals-4 (Dec 2019)

1. November 2019: The Food and Drug Administration granted accelerated approval to voxelotor in patients with sickle cell disease. NOT true about this drug is ?

2. NOV 2019: Which of these drug was FDA approved to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease ?

3. Which of the following is first and only FDA-approved erythroid maturation agent, representing a new class of therapy in beta thalassemia which works by regulating late-stage red blood cell maturation to help patients reduce their RBC transfusion burden ?

4. As of December 2019, Which of the following is not the approved indication of acalabrutinib ?

5. Which of the following is only approved indication of zanubrutinib (Q Last Updated May 2020) ?

6. Which of the following is true for approved indications of 1st line daratumumab in multiple myeloma (Q Last updated in May 2020) ?

7. CASSIOPEIA trial lead to approval of daratumumab in which of the following indications ?

8. FDA approval of daratumumab in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) was based on ?

9. Fedratinib is approved for ?

10. FDA granted accelerated approval to polatuzumab vedotin in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies in june 2019. What is MOA of polatuzumab vedotin ?

11. The approved indications of ruxolitinib are all except (Q Last updated in May 2020) ?

12. Ivosidenib is approved for newly-diagnosed AML with a susceptible IDH1 mutation as 1st line in which of the following conditions ?