High-dose chemotherapy, with or without total body radiation, followed by bone marrow transplantation to restore bone marrow function has been used widely in the treatment of malignant diseases in recent years (Medical Letter, 34:79, 1992; 37:25, 1995). Now, however, instead of using bone marrow itself to restore function destroyed by chemotherapy and radiation, many centers infuse hematopoietic stem cells harvested from peripheral blood. Most stem cell transplants have been autologous; allogeneic stem cells have been tried in a small number of patients (WI Bensinger et al, Blood,...

Enfortumab vedotin-ejfv (Padcev – Astellas), a nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for use with the immune checkpoint inhibitor pembrolizumab (Keytruda) for treatment of locally advanced or metastatic urothelial cancer in adults who are ineligible for cisplatin-containing chemotherapy. Accelerated approval was based on tumor response rates and the durability of response.

Patients with lung cancer may be asking their physicians about gefitinib (ge fi' tye nib; ZD1839; Iressa -- AstraZeneca), because it has been the subject of positive coverage in the media. An inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, this oral drug has not been approved by the FDA, but is in clinical trials in the US for treatment of non-small cell lung cancer (NSCLC) and some other solid tumors. Iressa was recently approved in Japan, and is available from the manufacturer on a "compassionate-use" basis in the US (800-236-9933).

The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are diagnosed each year with MCC. Most of these patients can be treated with surgical resection, but ~50% will have a recurrence and >30% will eventually have metastatic disease. Median progression-free...

The FDA has warned that the IV emulsion formulation of the substance P/neurokinin 1 (NK1) receptor antagonist rolapitant (Varubi) has been associated in postmarketing reports with serious hypersensitivity reactions including anaphylaxis and anaphylactic shock.1 Rolapitant was approved by the FDA as an oral tablet in 2015 for adjunctive prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults2; the IV emulsion formulation of the drug was approved for the same indication in 2017.The reported hypersensitivity reactions occurred during or shortly after infusion of...

Bexxar, a combination of the monoclonal antibody tositumomab and radiolabeled Iodine-131 tositumomab (Corixa Corp/GlaxoSmithKline) has been approved by the FDA for a single treatment of relapsed follicular non-Hodgkin's lymphoma (NHL) in patients who are refractory to rituximab (Rituxan - Medical Letter 1998; 40:65). It is the second radioimmunoconjugate to be approved for refractory NHL; yttrium-90 linked to ibritumomab tiuxetan (Zevalin) was approved in 2002. Tositumomab, like ibritumomab, is a monoclonal antibody of mouse origin that binds to the CD20 antigen present on the surface of >90%...

Nabilone (Cesamet - Lilly), a synthetic cannabinoid chemically related to tetrahydrocannabinol (THC), the main active ingredient in marijuana, was recently marketed in the USA for oral treatment of nausea and vomiting associated with cancer chemotherapy. Oral THC itself, known generically as dronabinol (Marinol), is also commercially available as an antiemetic for cancer patients (Medical Letter, 27:97, 1985). Other drugs used for this purpose include metoclopramide (Reglan - Medical Letter, 24:67, 1982), prochlorperazine (Compazine; and others), haloperidol (Haldol; and others), and...

The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....