Zongertinib (Hernexeos – Boehringer Ingelheim), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC) with human epidermal growth factor 2 (HER2) tyrosine kinase domain activating mutations who had received prior systemic therapy. It is the first oral targeted therapy to be approved in the US for this indication. The intravenous HER2-directed antibody and topoisomerase inhibitor conjugate famtrastuzumab deruxtecan (Enhertu) was approved for the same indication...

Nabilone (Cesamet - Lilly), a synthetic cannabinoid chemically related to tetrahydrocannabinol (THC), the main active ingredient in marijuana, was recently marketed in the USA for oral treatment of nausea and vomiting associated with cancer chemotherapy. Oral THC itself, known generically as dronabinol (Marinol), is also commercially available as an antiemetic for cancer patients (Medical Letter, 27:97, 1985). Other drugs used for this purpose include metoclopramide (Reglan - Medical Letter, 24:67, 1982), prochlorperazine (Compazine; and others), haloperidol (Haldol; and others), and...

The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

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...

Temozolomide has received accelerated approval from the FDA for oral treatment of adults with anaplastic astrocytoma that has relapsed after treatment with a nitrosourea (lomustine or carmustine) and procarbazine.

Bortezomib (PS341; Velcade Millenium), the first proteasome inhibitor, has received accelerated approval from the FDA for treatment of refractory multiple myeloma. This review includes descriptions of the mechanism of action, pharmacokinetics, adverse effects, and dosage and cost of bortezomib, outlines the results of clinical studies, and concludes with an overall assessment of the drug's effectiveness.

The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.

The FDA has approved the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris – Seattle Genetics) for use in combination with chemotherapy for IV treatment of adults with previously untreated stage 3 or 4 classical Hodgkin's lymphoma (cHL). Adcetris was approved earlier for consolidation treatment of cHL and for treatment of relapsed or refractory cHL, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.FDA approval for the new indication was based on the results of an open-label trial (ECHELON-1) in 1334 patients with previously untreated stage 3 or 4 cHL.1...