The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Osimertinib is the first targeted therapy to be approved in the US for this indication. The drug was previously approved for first-line treatment of adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and for treatment of EGFR T790M mutation-positive NSCLC in adults whose disease progressed...

Orlistat, a lipase inhibitor that decreases absorption of fat from the gastrointestinal tract, is now available for treatment of obesity.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

The oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) has been approved by the FDA for treatment of giant cell arteritis. Upadacitinib was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.

The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

An advertising war between manufacturers of over-the-counter (OTC) analgesics has led some patients to ask their physicians about the safety of taking these products if they also drink alcohol.

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.

The FDA has granted accelerated approval to copanlisib (Aliqopa – Bayer), an intravenously administered phosphatidylinositol 3-kinase (PI3K) inhibitor, for treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Follicular lymphoma is a common subtype of non-Hodgkin's lymphoma. Copanlisib is the second PI3K inhibitor to be approved for this indication; idelalisib (Zydelig), which is administered orally twice daily, was the first.