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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 June 21, 2022

Echinocandins

Echinocandins are noncompetitive inhibitors of beta-D-glucan synthesis by interfering key catalytic subunits (Fks1p and Fks2p) in the beta-(1,3)-D-glucan synthase enzyme complex, echinocandins deplete cell wall glucan crosslinking, resulting in a markedly weakened cell wall structure. Which of the following is true for their clinical use ?

Under sessile biofilm-like conditions, the MICs for amphotericin B and fluconazole may increase by 10- to 1000-fold whereas echinocandin MICs are minimally affected when tested in biofilm versus non-biofilm conditions.

Echinocandins may be particularly useful antifungal agents for prosthetic device or catheter-associated infections in which biofilm-embedded organisms can be associated with recurrent candidemia.

Biofilm growth in C. albicans is associated with increased secretion of carbohydrates, including beta-(1,3)-D-glucan.

All of the above statements are true for echinocandins activity against biofilm-embedded Candida species.

All Drug Update Quizes

Created on June 21, 2022

Poll of the Week 6

Micafungin, caspofungin and anidulafungin are not active at clinically relevant concentrations against all of these except ?

Zygomycetes

Cryptococcus neoformans

Fusarium spp

Aspergillus spp

Trichosporon spp

Micafungin, caspofungin and anidulafungin are not active at clinically relevant concentrations against Zygomycetes, Cryptococcus neoformans, Fusarium spp., or Trichosporon spp.

Echinocandins show fungicidal activity against both C. albicans and a large group of non-albicans species, including species such as C. glabrata and C. krusei, which are intrinsically resistance to triazoles, and C. lusitaniae resistance to amphotericin B.

In cases of Aspergilli, echinocandins have fungistatic activity and reduce invasion via damage of hyphae and branching.

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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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