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.

Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for first-line treatment of diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) in adults who have an International Prognostic Index (IPI) score ≥2. The drug was previously approved for use in combination with bendamustine and rituximab for treatment of patients with relapsed or refactory DLBCL,...

The FDA has approved diazoxide choline extended-release tablets (Vykat XR – Soleno Therapeutics) for treatment of hyperphagia in patients ≥4 years old with Prader-Willi syndrome. Diazoxide choline is the first drug to be approved in the US for this indication. Diazoxide oral suspension (Proglycem) has been available for years for management of symptomatic hypoglycemia.

Docetaxel (Taxotere - Rh ne-Poulenc Rorer), a semisynthetic taxoid similar to paclitaxel (Taxol - Medical Letter, 35:39, 1993), has been approved by the US Food and Drug Administration for use in locally advanced or metastatic breast cancer that has progressed or relapsed during treatment that included an anthracycline such as doxorubicin (Adriamycin, and others).

Rebetron, a combination of injected recombinant interferon alfa-2b with oral ribavirin has been approved by the FDA for treatment of chronic hepatitis C virus infection.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.

The FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal cell cancer, locally advanced basal cell carcinoma that has recurred after surgery, or locally advanced basal cell carcinoma in adults who are not candidates for surgery or radiation.

Terfenadine (Seldane - Marion Merrell Dow) and astemizole (Hismanal - Janssen) are nonsedating antihistamines widely used to treat symptoms of allergic rhinitis (Medical Letter, 27:65, 1985; 31:43, 1989). Both are available without a prescription in Canada, and the US Food and Drug Administration is apparently considering terfenadine for over-the-counter availability in the USA.

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

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.