In 2007, Merck voluntarily recalled some lots of PedvaxHIB and Comvax, two Haemophilus influenzae type b (Hib) vaccines, and temporarily stopped their production because of possible contamination, resulting in a shortage during which pediatricians were urged to defer giving Hib booster doses (normally given at 12-15 months) to healthy children. Now the FDA has granted accelerated licensure of Hiberix (GlaxoSmithKline), a monovalent vaccine conjugated with tetanus toxoid that has been used in Europe since 1996, as a booster (final) dose of the Hib series in children 15 months-4 years old....

The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases and are associated with advanced disease and a poor prognosis. Tepotinib received accelerated approval for the same indication in 2021 based on initial overall response rates and duration of response.

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

A reader has asked us to review the use of propofol (Diprivan, and others) as a sedative agent for brief procedures, such as colonoscopy.First marketed more than 20 years ago,1 propofol has a rapid onset of action (patients usually lose consciousness in less then one minute) and a short duration of action with a rapid recovery (3-5 minutes) that makes it highly suitable for brief ambulatory procedures. Propofol is now the most commonly used parenteral anesthetic in the US.2 The main problems with its use have been pain on injection and bacterial contamination, both related to its lipid...

The FDA has approved defibrotide sodium (Defitelio – Jazz), a mixture of mostly single-stranded polydeoxyribonucleotide sodium salts, for treatment of adults and children with hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome) and renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is the first drug to be approved by the FDA for treatment of severe hepatic veno-occlusive disease. Defibrotide was approved earlier by the European Medicines Agency for the same indication.Hepatic veno-occlusive disease is an uncommon (<2%)...

The FDA now requires boxed warnings in the package inserts of benzodiazepines describing the potential for these drugs to be abused and misused and to cause addiction and physical dependence. Benzodiazepine labels have contained a boxed warning about a risk of serious drug interactions with opioids since 2016.

The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

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