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Precision medicine strengthened its place in cancer care in the US, with over 65 agents receiving accelerated, regular, or expanded approvals in 2024. But these weren’t the only game-changing indications the regulatory agency greenlit throughout the year—label updates, biosimilar approvals, and new formulations of drugs housed under accelerated, regular, or expanded pathways also changed practice.

In addition to exciting new indications presenting crucial options for patients, several drugs missed the mark and were withdrawn from the market in 2024; these included melphalan flufenamide (Pepaxto; Melflufen), infigratinib (Truseltiq), and sacituzumab govitecan-hziy (Trodelvy) in certain populations.

“There are considerations and changes that need to occur within the different practices to accommodate [the changing field]; we want universal genetic testing provided to patients because for most tumors it’s becoming the exception of the rule to see guidelines that are not including biomarker-based approaches,” Pedro Barata, MD, said in an interview with OncLive^® on the changing oncologic landscape.

Throughout the year, we covered all the critical regulatory decisions that will affect practice. Keep reading to for a list of the label updates and new formulation/biosimilar approvals as well as label updates.

Melphalan flufenamide (Pepaxto; Melflufen)

Indication: In combination with dexamethasone to treat certain patients with multiple myeloma
Month: February
To read more, visit: bit.ly/3DmAMbC

Infigratinib (Truseltiq)

Indication: Previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement
Month: May
To read more, visit: bit.ly/4iIVXEL

Sacituzumab govitecan-hziy (Trodelvy)

Indication: Adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and PD-(L)1 inhibitor
Month: October
To read more, visit: bit.ly/3VIBeas

Reduced biweekly teclistamab-cqyv (Tecvayli) dose

Indication: A reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months
Month: February
To read more, visit: bit.ly/4goYanl

Safety labeling for fluorouracil

Indication: Safety label changes for fluorouracil injection products to include additional information regarding the risk of serious adverse effects in patients with dihydropyrimidine dehydrogenase deficiency
Month: March
To read more, visit: bit.ly/4gGXKIT

Labeling for fludarabine phosphate (Fludarabine Phosphate Injection)

Indication: Now approved as a component of a combination regimen for the treatment of adults with B-cell CLL and for those who have not responded to or whose disease has progressed during treatment with at least 1 alkylating agent–containing regimen; additional label revisions occurred regarding dosing and removal of the boxed warning
Month: November
To read more, visit: bit.ly/4iDdm1H

Oral suspension formulation of ibrutinib (Imbruvica)

Indication: A label expansion for ibrutinib with an oral suspension formulation for the treatment of adult patients with CLL/SLL, Waldenström macroglobulinemia, and cGVHD after failure on at least 1 line of systemic therapy
Month: February
To read more, visit: bit.ly/4iI02sK

Tepylute (formerly SH-105), a ready-to-dilute formulation of thiotepa

Indication: Adenocarcinoma of the breast and ovary
Month: June
To read more, visit: bit.ly/4gvoBaG

Bortezomib injectable (Boruzu)

Indication: Multiple myeloma and MCL
Month: September
To read more, visit: bit.ly/4e8dz9Q

Nilotinib (Danziten) tablets without mealtime restrictions

Indication: Adult patients with newly diagnosed Ph-positive CML in CP and adult patients with CP and acute phase resistant or intolerant to prior therapy including imatinib (Gleevec)
Month: November
To read more, visit: bit.ly/3Op8PCe

Oral solution of imatinib (Imkeldi)

Indication: Certain forms of leukemia and other cancers
Month: November
To read more, visit: bit.ly/3VESzkz

Single-dose, intravenous generic formulation of paclitaxel

References: Paclitaxel; the biosimilar is a single-dose, generic formulation of paclitaxel comprising paclitaxel protein-bound particles (albumin-bound) for injectable suspension.
Indication: Metastatic breast cancer
Month: October
To read more, visit: bit.ly/3NPgJo6

Trastuzumab-strf (HLX02; Hercessi)

References: Trastuzumab (Herceptin)
Indication: Adjuvant treatment of HER2-overexpressing breast cancer, treatment of HER2-overexpressing metastatic breast cancer, and treatment of HER2-overexpressing metastatic gastric or GEJ adenocarcinoma
Month: April
To read more, visit: bit.ly/41FQJUe

Denosumab-bbdz (Wyost) and denosumab-bbdz (Jubbonti)

References: Denosumab (Xgeva and Prolia); both denosumab-bbdz biosimilars are the first FDA-approved denosumab biosimilars.
Indication: All indications of the reference medicines
Month: March
To read more, visit: bit.ly/3Bp2p3c

Reference

1. Advancing health through innovation: New drug therapy approvals 2024. FDA. Accessed February 4, 2025. bit.ly/3WKqf0s