Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated May 22, 2020)

The FDA has approved the following drugs:
  • Bafiertam (monomethyl fumarate) oral delayed-release capsules to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
  • Qinlock (ripretinib) oral tablets to treat adults with advanced GI stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • Retevmo (selpercatinib) oral capsules to treat adults with metastatic RET fusion–positive non–small cell lung cancer; adult and pediatric patients 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy; and adult and pediatric patients 12 years and older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are radioactive iodine–refractory (if radioactive iodine is appropriate). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.
  • Tolvaptan oral tablets, the generic version of Samsca, to treat significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less, marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone. Labeling includes a Boxed Warning regarding the need to initiate and reinitiate in a hospital, monitor serum sodium and avoid use for autosomal dominant polycystic kidney disease.
  • Stahist TP (triprolidine/phenylephrine) oral tablets for the temporary relief of runny nose; sneezing; itching of the nose or throat; itchy, watery eyes; nasal congestion; and to reduce swelling of nasal passages due to common cold, allergic rhinitis, or other respiratory allergies.
  • Tabrecta (capmatinib) oral tablets to treat adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.
 
The FDA has approved the following new indications:
  • Two new indications for Lynparza (olaparib) oral tablets:
    • In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA-mutation, and/or genomic instability. 
    • To treat adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone. 
  • Pomalyst (pomalidomide) oral capsules to treat Kaposi sarcoma (KS) in adults with AIDS-related KS (after failure of highly active antiretroviral therapy) and in adults with KS who are HIV-negative. Pomalyst is available only through a restricted access program under a Risk Evaluation and Mitigation Strategy (REMS). Major risks include embryo-fetal toxicity and venous and arterial thromboembolism. 
  • Rubraca (rucaparib) oral tablets to treat adult patients with a deleterious BRCA mutation (germline and/or somatic)–associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and a taxane-based chemotherapy. Rubraca is also approved for ovarian cancer.
  • Tecentriq (atezolizumab) intravenous injection for the first-line treatment of metastatic non-small cell lung cancer in adult patients whose tumors have high programmed death-ligand 1 (PD-L1) expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. 
  • Yervoy (ipilimumab) intravenous injection, in combination with nivolumab, for the first-line treatment of adult patients with metastatic non–small cell lung cancer whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Major risks include immune-mediated adverse reactions.

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