An oral extended-release formulation of the corticosteroid budesonide (Ortikos – Ferring) is now available for once-daily treatment of mild to moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8 years old and for maintenance of remission for up to 3 months in adults. Ortikos is the second oral formulation of budesonide to be approved for this indication; Entocort EC, an ileal-release formulation, was the first. A third oral formulation of budesonide (Uceris) is approved for induction of remission in patients with mild to moderate active ulcerative...

The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular Assay (Third Wave Technologies) detects the UGT1A1*28 allele, a variation in the uridine diphosphate glucuronosyltranferase 1A1 (UGT1A1) gene. The FDA recently revised the safety labeling for irinotecan, recommending that the dosing of irinotecan be reduced for patients who are homozygous for the UGT1A1*28 allele.

Apriso (Salix) is a new formulation of mesalamine (5-aminosalicylic acid; 5-ASA) approved by the FDA for maintenance of remission in mild to moderate ulcerative colitis (UC). Mesalamine is a locally acting antiinflammatory agent that is widely used both to maintain and induce remission in inflammatory bowel disease. Various mesalamine formulations have been developed to target drug delivery to areas of the small intestine and colon. Most of these agents require frequent dosing and have a high pill burden. The newest products - Lialda, introduced in 2007,1 and now Apriso - can be dosed once...

The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have unresectable or metastatic microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) solid tumors that have progressed following treatment, and do not have any satisfactory alternative treatment options. For metastatic colorectal cancer, the indication is limited to tumors that have progressed following combination treatment with a fluoropyrimidine, oxaliplatin, and...

The gram-positive anaerobic bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea. The antibiotics most often implicated have been ampicillin, second and third generation cephalosporins, clindamycin and fluoroquinolones. The emergence in recent years of a new, more toxic epidemic strain (BI/NAP1), possibly related to widespread use of fluoroquinolones, has caused a marked increase in the incidence and severity of C. difficile-associated disease (CDAD).

Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other regimens specified in the labeling. It has also been approved for use in treatment-refractory, locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).

The CDC has issued a recommendation for use of a single dose of doxycycline for post-exposure prophylaxis (PEP) of bacterial sexually transmitted infections (STIs), specifically syphilis, chlamydia, and gonorrhea, in men who have sex with men (MSM) and transgender women (TGW) who had a bacterial STI within the previous 12 months.

Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a response rate of only 8.9%, but increased median survival from 4.7 to 6.7 months. Patients who had never smoked and those with EGFR-positive tumors survived longer. Erlotinib is generally well tolerated; diarrhea and rash are the most common adverse effects.

Panitumumab (Vectibix - Amgen), a fully human IgG₂ monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), has been approved by the FDA for treatment of patients with EGFR-expressing metastatic colorectal cancer that has progressed despite standard chemotherapy. It is the second monoclonal antibody EGFR inhibitor to be approved for metastatic colorectal cancer; cetuximab (Erbitux), a human-murine chimeric IgG₁ monoclonal antibody, was approved in 2004.

The FDA has approved the 5-HT4 receptor agonist prucalopride (Motegrity – Shire) for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride is the only drug currently approved in the US for treatment of CIC that stimulates colonic peristalsis. It has been available in Europe and Canada for several years.