The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia chrysanthemi, for use in combination with other chemotherapeutic agents for treatment of acute lymphoblastic leukemia (ALL) in patients who have had allergic reactions to Escherichia coli-derived asparaginase (Elspar or pegaspargase [Oncaspar]).ALL is the most common malignancy of childhood. Multidrug chemotherapy can cure about 80% of children with ALL.1 Initial treatment ("induction") usually includes vincristine, a glucocorticoid, and an...

Cetuximab (Erbitux - ImClone Systems/Bristol-Myers Squibb), an epidermal growth factor receptor (EGFR) inhibitor, and bevacizumab (Avastin - Genentech), the first vascular endothelial growth factor angiogenesis inhibitor, have recently been approved by the FDA for treatment of patients with metastatic colorectal cancer. Cetuximab is approved for treatment of patients with EGFR-expressing tumors, either in combination regimens with irinotecan (Camptosar)when the cancer has progressed on irinotecan-based therapy, or as monotherapy for those who cannot tolerate irinotecan. Bevacizumab is approved...

Acupuncture is the practice of inserting fine needles for therapeutic purposes into points on the skin known as acupoints. In traditional Chinese medicine theory, these points arefound along channels that conduct "qi" (pronounced "chee"), or energy. In addition to insertion of needles, acupoints can be stimulated by heat, electrical current or just pressure.

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.

The oral kinase inhibitors selpercatinib (Retevmo – Lilly) and pralsetinib (Gavreto – Blueprint Medicines/Genentech) have been approved by the FDA for treatment of advanced or metastatic RET-mutant or RET fusion-positive cancers. They are the first drugs to be approved specifically for certain RET-driven cancers. Both drugs were granted accelerated approval based on overall response rates and the duration of response.

The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. Repotrectinib is the third oral tyrosine kinase inhibitor to be approved for this indication in the US; crizotinib (Xalkori) and entrectinib (Rozlytrek) were approved earlier.

The FDA has approved use of dinutuximab (Unituxin [yoo ni tux' in] – United Therapeutics) in combination with interleukin-2 (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin for treatment of children with high-risk neuroblastoma who previously responded to first-line therapies. Dinutuximab is a monoclonal antibody that binds to GD2, a glycolipid that is overexpressed on the surface of neuroblastoma cells.1Dinutuximab received a priority review and orphan drug designation. Approval was based on the results of an open-label trial in 226 patients with high-risk...

A topical formulation of the antimetabolite mitomycin (Mitosol – Mobius Therapeutics) has been approved by the FDA for adjunctive use in glaucoma surgery to reduce scarring. Compounding pharmacies have supplied the drug off-label for this purpose for many years.

Mitoxantrone (Novantrone - Lederle), a synthetic anthracene related to the anthracyclines doxorubicin (Adriamycin) and daunorubicin (Cerubidine), has now been marketed in the USA to be used in combination with other drugs for initial treatment of acute nonlymphocytic leukemia in adults.

Doripenem (Doribax - Ortho-McNeil Janssen), an intravenous (IV) carbapenem antibiotic with a spectrum of activity similar to that of imipenem and meropenem, has been approved by the FDA for treatment of complicated intra-abdominal and urinary tract infections. Use of doripenem for treatment of nosocomial pneumonia, including ventilator-associated pneumonia, is still under FDA review.