The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

Epcoritamab-bysp (Epkinly – Genmab), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for subcutaneous treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after ≥2 lines of systemic therapy. Epcoritamab is the second T-cell-engaging bispecific antibody to become available in the US for treatment of non-Hodgkin's lymphoma; mosunetuzumab-axgb (Lunsumio) was recently approved for relapsed or refractory...

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for 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 overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

The FDA has approved vorasidenib (Voranigo – Servier), an oral isocitrate dehydrogenase (IDH) inhibitor, for treatment of grade 2 astrocytoma or oligodendroglioma in patients ≥12 years old with an IDH1 or IDH2 mutation. It is the first systemic treatment to be approved in the US for this indication.

The oral kinase inhibitor osimertinib (Tagrisso – AstraZeneca), which has been available for years for treatment of non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, has now been approved for treatment of unresectable stage III EGFR-mutated NSCLC. About 20-30% of patients with NSCLC have locally advanced stage III NSCLC, and 60-90% of these patients have unresectable disease. Osimertinib is the first targeted therapy to be approved for the new indication.

Levamisole (Janssen), an old antiparasitic drug widely used for treatment of ascariasis in animals, is now available from the National Cancer Institute (NCI) for investigational use with fluorouracil (5-FU; Adrucil; and others) as an adjuvant for treatment of resectable colon cancer that has metastasized to regional lymph nodes (Dukes stage C).

Pentostatin (2'-deoxycoformycin; DCF; - Parke-Davis), a purine analog, was recently approved by the US Food and Drug Administration (FDA) for treatment of hairy-cell leukemia resistant to interferon alfa (Intron A; Roferon-A). is a rare (500 cases/year in the USA) form of chronic lymphocytic leukemia. Acutely ill patients may respond rapidly to interferon, but the drug is rarely curative. Another purine analog, 2-chlorodeoxyadenosine (CdA; Leustatin - Ortho Biotech), may also be approved soon for treatment of hairy-cell leukemia (JD Piro, Blood, 79:843, 1992). Fludarabine (Fludara...

Rituximab (Rituxan - IDEC Pharmaceutical/Genentech), a monoclonal antibody, has been approved by the FDA for treatment of low-grade B-cell non-Hodgkin's lymphoma. Most low-grade lymphomas are B-cell lymphomas.

The FDA has approved abiraterone acetate (Zytiga – Centocor Ortho Biotech) for oral treatment, in combination with prednisone, of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and others). It is the first oral drug approved for this indication. Zytiga will compete with cabazitaxel (Jevtana) and sipuleucel-T (Provenge).

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.