The FDA has approved axicabtagene ciloleucel (Yescarta – Kite) for treatment of adults with relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. It is the second CAR T-cell immunotherapy to become available in the US. Tisagenlecleucel (Kymriah), a CAR T-cell product previously approved for treatment of relapsed or refractory B-cell...

The FDA has approved idecabtagene vicleucel (Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Abecma is an individualized cellular product prepared from the patient’s own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Ciltacabtagene autoleucel...

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.

Recent reports of inappropriate use and diversion of OxyContin tablets have prompted Purdue Pharma to include a "Black Box Warning"in the product labeling to call attention to the potential for abuse and to reinforce the FDA-approved indication "...for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time..."

Since the last Medical Letter article on glucosamine for osteoarthritis (vol.39, page 91, September 26, 1997), more data have become available. Glucosamine is available in US pharmacies and health food stores as sulfate, hydrochloride or n-acetyl salt.

The FDA recently approved axicabtagene ciloleucel (Yescarta – Kite), a CD19-directed genetically modified cellular product, for treatment of large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line treatment. It was previously approved for treatment of relapsed or refractory B-cell lymphoma after ≥2 lines of systemic therapy and for treatment of relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells,...

The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B who have disease refractory to first-line chemoimmunotherapy, relapsed within 12 months of or after first-line chemoimmunotherapy, are not eligible for hematopoietic stem cell transplantation due to comorbidities or age, or have relapsed or refractory disease after ≥2 lines of...

Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

The FDA has approved a single-injection hyaluronic acid gel (Durolane – Bioventus) and an extended-release (ER) formulation of the synthetic corticosteroid triamcinolone acetonide (Zilretta – Flexion) for intra-articular (IA) treatment of osteoarthritic knee pain.

Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.