Epirubicin, an analog of doxorubicin that has been available in Europe and Canada for 15 years, has now been approved by the FDA for adjuvant use after resection of the primary tumor in breast cancer patients with axillary node involvement.

Idarubicin hydrochloride (Idamycin - Adria), an anthracycline structurally related to daunorubicin (Cerubidine, and others) and doxorubicin (Adriamycin, and others), was recently approved in the USA for treatment of acute myelogenous leukemia (AML) in adults.

Valrubicin (Valstar), formerly known as AD 32, has been approved by the FDA for intravesical treament of bladder cancer. The approval is limited to patients with carcinoma-in-situ refractory to BCG for whom immediate cystectomy is contraindicated.

Recent studies have caused concern about cardiomyopathy associated with doxorubicin (Adriamycin, and others), daunorubicin (Cerubidine, and others), idarubicin (Idamycin), mitoxantrone (Novantrone), and related anthracycline or anthraquinone anticancer drugs. Dexrazoxane (ADR-529, ICRF-187 - Adria), a piperazine derivative of ethylenediaminetetraacetic acid (EDTA), is now under investigation for prevention of this drug-induced cardiomyopathy.

Pegaspargase (peg as par jase; PEG-L-asparaginase; Oncaspar - Rh ne-Poulenc Rorer), a polyethylene glycol (PEG) conjugate of L-asparaginase, has been approved by the US Food and Drug Administration for treatment of acute lymphoblastic leukemia (ALL), the most common malignancy of childhood. The new drug is recommended only for patients who have had allergic reactions to asparaginase. Asparaginase is available commercially as Elspar, which is derived from Escherichia coli. A formulation derived from Erwinia chrysanthemi is available on an investigational basis (Ogden Bioservices,...

Dexrazoxane (Zinecard - Pharmacia) was recently approved by the US Food and Drug Administration (FDA) for protection against cardiac toxicity from (Adriamycin, and others) in women with metastatic breast cancer.

BCG Live (TheraCys - Connaught) and BCG Vaccine U.S.P. (TiceBCG - Organon), freeze-dried suspensions of an attenuated strain of Mycobacterium bovis, were recently approved by the US Food and Drug Administration for intravesical treatment of primary or relapsed carcinoma in situ of the bladder, with or without associated papillary tumors. BCG is not recommended for treatment of papillary tumors occurring alone.

Altretamine (Hexalen - US Bioscience; Hexastat - Rh ne-Poulenc in Canada), formerly known only by its chemical name, hexamethylmelamine, was recently approved by the US Food and Drug Administration as a single agent for palliative oral treatment of persistent or recurrent ovarian cancer.

The US Food and Drug Administration (FDA) has approved use of recombinant human interleukin 11 (rhIL-11; oprelvekin; Neumega - Genetics Institute) to increase platelet counts and decrease the need for platelet transfusions in patients with severe thrombocytopenia caused by chemotherapy for nonmyeloid malignancies.

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.