The immune checkpoint inhibitor dostarlimab-gxly (Jemperli – GSK) has been approved by the FDA for use in combination with carboplatin and paclitaxel for treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. Dostarlimab was recently granted regular approval for treatment of adults with dMMR recurrent or advanced endometrial cancer that progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

Obecabtagene autoleucel (Aucatzyl – Autolus), a CD19-directed genetically modified autologous T cell immunotherapy, has been approved by the FDA for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. The CAR T-cell immunotherapy products tisagenlecleucel (Kymriah) and brexucabtagene auto-leucel (Tecartus) were approved earlier for the same indication.

The FDA has approved brigatinib (Alunbrig – Takeda), an oral tyrosine kinase inhibitor, for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma. Brigatinib is the third tyrosine kinase inhibitor to be approved for this indication; ceritinib (Zykadia) and alectinib (Alecensa) were approved earlier, and subsequently were...

The US Food and Drug Administration recently approved the marketing of goserelin acetate (Zoladex - ICI Pharma), an implant for palliative treatment of advanced prostate cancer. Goserelin acetate is a synthetic decapeptide luteinizing hormone-releasing hormone (LH-RH) analog similar to leuprolide (Lupron; Lupron Depot) (Medical Letter, 27:71, 1985).

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.

Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved for treatment of relapsed or refractory mantle cell lymphoma. Tecartus is an individualized cellular product prepared from the patients own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell immunotherapy tisagenlecleucel (Kymriah) was approved in 2017 for treatment of relapsed or refractory...

Flutamide (Eulexin - Schering), an oral antiandrogen, is now available in the USA for treatment of metastatic prostate cancer. Flutamide is recommended by the manufacturer only for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron - Medical Letter, 27:71, 1985).

Topotecan hydrochloride (Hycamtin - SmithKline Beecham) was recently approved by the U.S. Food and Drug Administration for parenteral use as a single agent in patients with metastatic ovarian cancer refractory to other drugs. Initial treatment for metastatic ovarian cancer usually consists of cisplatin (Platinol) or carboplatin (Paraplatin) plus paclitaxel (Taxol) or cyclophosphamide (Cytoxan, and others).

A biodegradable polymer 'wafer' (Gliadel - Rh ne-Poulenc Rorer) impregnated with the alkylating agent carmustine (BCNU; Bicnu) has been marketed in the USA for local treatment of recurrent glioblastoma multiforme that requires re-operation. The dime-sized polyanhydride wafers are implanted into the surgical cavity left behind after resection. Release of the alkylating agent directly into the area of the tumor bypasses the blood-brain barrier (H Brem and R Langer, Sci Med, 3:1, 1996).

Ceritinib (Zykadia – Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). It is the second tyrosine kinase inhibitor to be approved for ALK-positive metastatic NSCLC; crizotinib was the first. Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma.