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FDA Approval News

Malignant
BMT
Benign

1/04/2022: FDA approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. Approval was based on ZUMA-7 trial.

29/10/2021: FDA granted accelerated approval to asciminib (Scemblix, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I mutation.

1/10/2021: FDA approved brexucabtagene autoleucel for adult patients with relapsed or refractory B-cell ALL. Efficacy was evaluated in ZUMA-3 (NCT02614066), a single-arm multicenter trial that evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in adults with relapsed or refractory B-cell precursor ALL.

14/9/2021: FDA granted accelerated approval to zanubrutinib for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

1/9/2021: FDA approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), a randomized, active control, open-label trial, comparing zanubrutinib and ibrutinib in patients with MYD88 L265P mutation (MYD88MUT) WM.

16/6/2021: FDA approved avapritinib for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

15/12/2021: FDA approved abatacept for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. This is the first drug approved to prevent aGVHD. Approval was based on GVHD-1 (NCT 01743131) trial.

23/11/2021: FDA approved maribavir as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV.

22/9/2021: FDA approved ruxolitinib for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Efficacy was evaluated in REACH-3, a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best available therapy (BAT) for corticosteroid-refractory cGVHD after allogeneic stem cell transplantation. (Read more about Ruxolitinib)

16/7/2021: FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Created on December 04, 2021

Maribavir

FDA has recently approved maribavir as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. The mechanism of action of maribavir is ?

Inhibits DNA polymerase (UL54 gene)

ATP competitor of viral UL97 kinase

Inhibits virion assembly

DNA terminal transferase complex binding

Maribavir is an orally available benzimidazole riboside compound with activity against cytomegalovirus (CMV). Maribavir is a selective ATP competitor of viral UL97 kinase, which is involved in viral nuclear maturation events, such as viral DNA assembly and movement of viral capsids from the nucleus of infected cells. Maribavir has activity against strains of CMV that are resistant to standard anti-CMV agents.

All Drug Update Quizes

Created on December 04, 2021

Poll of the Week 5

Which of the following is true for role of Letermovir in management of CMV Reactivation and Infection in Allogeneic Blood and Marrow Transplant Recipients?

Letermovir is approved for prophylaxis CMV disease in adult CMV-seropositive recipients

The recommended dose of Letermovir is 480 mg once daily PO/IV

If letermovir is co-administered with ciclosporin, the dosage of letermovir should be halved

All of these are true regarding role of Letermovir in management of CMV Reactivation and Infection

Letermovir is approved for prophylaxis CMV disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). The recommended dose is 480 mg once daily BUT, if letermovir is co-administered with ciclosporin, the dosage of letermovir should be decreased to 240 mg once daily. Letermovir should normally be started on the day of transplant (Day 0) (but it may be started any day up to 28 days post-transplant). Letermovir may be started before or after engraftment. Prophylaxis with Letermovir is normally stopped at day +100 post-transplant (unless stopped earlier in case of CMV reactivation requiring initiation of pre-emptive therapy).

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Online Calculators In Hematology

	MDS Calculators
1	Online MDS IPSS Calculator
2	Online MDS IPSS-R Calculator
	Coagulation Calculators
1	4T Clinical Score for HIT
2	Wells’ score calculator
3	Diagnostic criteria for APS

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