In the News

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.
  • FDA Resumes Operations After Government Shutdown End
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
On June 22, 2017, the FDA approved the combination of rituximab and hyaluronidase human (Rituxan Hycela; Genentech) for the treatment of adults with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), or chronic lymphocytic leukemia (CLL).
The 3-drug regimen should be considered a new standard of care. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma,” reported Antonio Palumbo, MD.
The first-in-class antibody-drug conjugate rovalpituzumab tesirine (Rova-T) may be a new treatment option for patients with small-cell lung cancer (SCLC), which has a very poor prognosis and few treatment options.
The influence of genetics on the risk for type 2 diabetes has been suggested by previous research, but new research from the NIH has now outlined in unprecedented detail the role of common genetic variants in the risk for this disease. “Our study has taken us to the most complete understanding yet of the genetic architecture of type 2 diabetes,” said Michael Boehnke, PhD.
While testifying before the Senate Committee on Finance on July 13, 2016, Acting Administrator for CMS Andrew Slavitt said that the agency would consider delaying the implementation of MACRA to address physician and stakeholder concerns. Signed into law in 2015, MACRA will dramatically change the way in which physicians caring for Medicare beneficiaries are paid. The final rule is expected to be released in November of 2016, with an intended start date of January 1, 2017.
On April 29, 2016, the US Food and Drug Administration (FDA) approved pimavanserin (Nuplazid; Acadia), an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson’s disease. Pimavanserin is the first drug approved by the FDA for hallucinations and delusions that are associated with Parkinson’s disease.
On May 27, 2016, the US Food and Drug Administration approved daclizumab (Zinbryta; Biogen), a long-acting injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab can be self-administered by the patient. Daclizumab is recommended for patients who had an inadequate response to ≥2 drugs for MS, because of its safety profile.
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