The FDA has approved omacetaxine mepesuccinate (Synribo – Teva), a cephalotaxine known for many years as homoharringtonine, for treatment of adults with chronic or accelerated phase chronic myeloid leukemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors.

The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil recovery and the risk of infection in patients ≥12 years old with hematologic malignancies who will undergo umbilical cord blood transplantation following myeloablative conditioning therapy. Hematopoietic progenitor cell (HPC) umbilical cord products (e.g., Allocord, Clevecord, Ducord) have been available in the US for years for the same indication. Cord blood banks also supply cord...

Dasatinib (Sprycel - Bristol-Myers Squibb), an inhibitor of multiple tyrosine kinases, has been approved by the FDA for second-line treatment of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.1 It is the only VZV vaccine currently available in the US; Zostavax, a live-attenuated VZV vaccine, was withdrawn from the market in 2020.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.

Palifermin (Kepivance - Amgen), a recombinant human keratinocyte growth factor (KGF), has been approved by the FDA to decrease the incidence and duration of severe oral mucositis (OM) in patients with hematologic malignancies receiving myelotoxic chemotherapy and hematopoietic stem cell (HSC) rescue.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

The RAS GTPase family inhibitor adagrasib (Krazati – BMS), which received accelerated approval for treatment of KRAS G12C (glycine-to-cysteine mutation at codon 12)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2022, has now received accelerated approval from the FDA for use with cetuximab for treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in adults who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Adagrasib is the first KRAS inhibitor to be approved in the US for treatment...