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FDA RoundUp: This Weeks FDA Approvals (August 2-9)

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FDA approves liquid biopsy for EGFR-positive lung cancer

The U.S. Food and Drug Administration has approved the Guardant360 CDx assay to identify patients with metastatic non-small cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) gene, according to a press release.
The diagnostic test used next-generation sequencing (NGS) and liquid biopsy together.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in a press release. “In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”

Read the full press release here.

FDA approves new opioid for intravenous use in controlled clinical settings

The U.S. Food and Drug Administration has approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use.

“Addressing the opioid crisis remains a top priority for the FDA. We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives,” said Douglas Throckmorton MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release. “Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness. Of note, this particular medication is only indicated for use in a controlled clinical setting, meaning under medical supervision and not for use in a take-home prescription.”

A total of 1,535 patients with moderate to severe acute pain were treated with Olinvyk in controlled and open-label trials. Its safety and efficacy were established by comparing Olinvyk to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery. Patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.

Read the full press release here.

FDA approves treatment for spinal muscular atrophy

The U.S. Food and Drug Administration risdiplam (Evrysdi), an at-home, oral treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older, according to a press release.

In 2 clinical trials, patents age 2 and older who received risdiplam showed clinically meaningful improvements in motor function and obtainment of developmental milestones. In addition, patients experience preserved vital functions and improved survival at 12 months.

“Given the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development in a press release. “The strength and resolve of the SMA community has continually inspired us as we developed this first-of-its-kind medicine for SMA, so today we celebrate our collective accomplishment together with them.”

Read the full press release here.

FDA expands dolutegravir/lamivudine indication for virologically suppressed adults with HIV

The US Food and Drug Administration has approved dolutegravir/lamivudine (Dovato) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of dolutegravir/lamivudine, according to a press release.

“As HIV treatment and care progress, people living with HIV will be on medication for decades and need solutions to challenges that may arise from prolonged use of ARV therapy. At ViiV Healthcare, we’ve proven that with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance. This remarkable, innovative approach challenges the notion that three or more drugs are needed to maintain virologic suppression, and today’s FDA approval brings this switch treatment option to virologically suppressed adults living with HIV,” said Lynn Baxter, Head of North America, ViiV Healthcare in a press release.

Read the full press release here.

 

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