The FDA has approved rolapitant (Varubi – Tesaro), an oral substance P/neurokinin 1 (NK₁) receptor antagonist, for use with other antiemetics to prevent delayed nausea and vomiting associated with cancer chemotherapy in adults. It is the third substance P/NK₁ receptor antagonist to be approved in the US; aprepitant (Emend) and netupitant (only available in combination with the 5-HT₃ receptor antagonist palonosetron as Akynzeo) were approved earlier for prevention of both acute and delayed chemotherapy-induced nausea and vomiting.

The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Accelerated approval was based on the overall response rate and duration of response. Futibatinib is the second drug to be approved for this indication; pemigatinib (Pemazyre) was approved earlier.

The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

Disodium pamidronate (Aredia - Ciba-Geigy), an aminohydroxypropilidene bisphosphonate, has been approved by the US Food and Drug Administration for intravenous (IV) treatment of hypercalcemia associated with malignancy, with or without bone metastases. The drug is also being investigated for use in Paget's disease of bone, hyperparathyroidism, and postmenopausal osteoporosis. An oral formulation of pamidronate has been used in Europe, but is not available in the USA.

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.

Nelarabine (Arranon - GlaxoSmithKline), a prodrug of the deoxyguanosine analog 9-β-D-arabinofuranosylguanine (ara-G), has been approved by the FDA for treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) that has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.

The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent urinary tract infection. Vasomotor symptoms (VMS; hot flashes, night sweats) often disrupt sleep.

Raloxifene (Evista - Lilly), a benzothiophene that acts on estrogen receptors, has recently been marketed for prevention of postmenopausal osteoporosis. Only estrogen (alone or in combination with a progestin) and the bisphosphonate alendronate (Fosamax) were previously approved by the FDA for this indication.

Intensive chemotherapy, with or without total body radiation, followed by bone marrow transplantation is now widely used in the treatment of malignant diseases. The drugs and radiation needed to try to eradicate the malignancy unavoidably destroy the bone marrow; intravenous infusion of bone marrow cells restores the marrow by repopulating it. Diseases for which bone marrow transplantation has been used include the leukemias and lymphomas, breast cancer, neuroblastoma, ovarian cancer, germ cell tumors, melanoma, multiple myeloma, and malignant gliomas (NC Gorin, Am J Clin On-col, 14...

The FDA has approved an estradiol softgel vaginal insert (Imvexxy – TherapeuticsMD) for treatment of postmenopausal women with moderate to severe dyspareunia due to vulvovaginal atrophy (VVA). Imvexxy is the second estradiol vaginal insert to be approved in the US; Vagifem, an intravaginal tablet formulation, was the first. Vagifem and Imvexxy are both available in inserts containing 10 mcg of estradiol; Imvexxy is also available in a 4-mcg strength.