Category: Medicine

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FDA Approves In-Home Breast Cancer Treatment

The US Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously — rather than intravenously — for the treatment of early and metastatic HER2-positive breast cancers.

Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified healthcare professional once chemotherapy is complete, according to the FDA.

Administration takes approximately 8 minutes for the initial loading dose and approximately 5 minutes for maintenance doses, according to a Genentech press statement. This compares favorably to the 150 minutes needed for the combined loading dose of intravenous pertuzumab and trastuzumab, and the 60-150 minutes for IV maintenance infusions, the company said.

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Temporary IVC Filter Reduces Neurosurgery Complications in Thrombophilic Patients

Thrombophilic patients undergoing elective neurosurgery who receive a temporary inferior vena cava (IVC) filter show dramatically fewer thrombotic or hemorrhagic complications compared with thrombophilia patients who do not have the filter placed, results from a randomized trial show.

“The use of a temporary IVC filter in thrombophilic patients that need elective cranial or spinal surgery is safe and statistically significantly lessens pulmonary embolisms, sudden death from saddle pulmonary embolism, and hemorrhagic complications due to early re-anticoagulation,” said Scott Shapiro, MD, Robert J. Campbell professor of neurosurgery at the Indiana University School of Medicine, in Indianapolis.

He presented the findings as part of the virtual American Association of Neurological Surgeons (AANS) 2020 Annual Meeting.

“This is a very easy strategy to implement in this high risk group and I strongly recommend (the) adoption of this approach,” he said.

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Ursodeoxycholic Acid May Prevent Gallstones After Gastrectomy

Ursodeoxycholic acid (UDCA) reduced gallstone formation after gastrectomy in a randomized, controlled study in Korea.

Dr. Do Joong Park of Seoul National University randomized 521 patients to 300 mg UDCA, 600 mg UDCA or placebo after total, distal or proximal gastrectomy. Gallstone formation was assessed with abdominal ultrasonography every three months for one year post-surgery.

As reported in JAMA Surgery, the full analysis dataset included 465 patients (median age 50; 69% men). The proportion of patients developing gallstones within 12 months after gastrectomy was 5.3% in the 300-mg group, 4.3% in the 600-mg group, and 16.7% in the placebo group.

Compared with placebo, odds ratios for gallstone formation were 0.27 for 300 mg UDCA and 0.20 for 600 mg.

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FDA OKs Implantable Neurostimulator(ReActiv8) for Intractable Low Back Pain

The US Food and Drug Administration (FDA) has approved an implantable neurostimulation system (ReActiv8, Mainstay Medical) to treat intractable chronic low back pain associated with multifidus muscle dysfunction found on imaging or physiologic testing in adults who have failed other therapies and are not candidates for spine surgery.

“ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back. Reactiv8’s stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in chronic low back pain and its disabling effects,” Mainstay Medical said in a release.

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