FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved an Amgen BLA for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. The company says that the drug has not been shown to improve overall survival or have an effect on visceral metastases.

DEVICES

FDA has cleared a Mauna Kea Technologies 510(k) for Cellvizio, a multidisciplinary confocal laser endomicroscopy platform for use in cancer surgical procedures. The device allows surgeons to have a real-time microscopic image of tissue during a surgical procedure to be able to identify cancerous tissue and guide treatment during surgery.

Masimo has received FDA 510(k) clearance for MightySat Rx, a fingertip pulse oximeter that uses the company’s SET Measure-through Motion and Low Perfusion technology. SET is present in all Masimo bedside devices and in many leading multi-parameter monitors, according to the company. The device measures arterial oxygen saturation and pulse rate, in addition to perfusion index and optional pleth variability index.

FDA has cleared a Pryor Medical Devices 510(k) for the ER-REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) catheter for use to temporarily occlude large vessels using a balloon. The device’s small (7 Fr) size precludes the need for additional surgical repair at the access site, according to the company, and it does not require multiple wire exchanges. Additionally, it features a soft, atraumatic tip and it allows simultaneous arterial pressure monitoring.

HUMAN DRUGS

FDA has approved an expanded use for Bristol-Myers Squibb’s Yervoy (ipilimumab) — adjuvant therapy for patients with Stage III melanoma to lower the risk that it will return following surgery. Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. The monoclonal antibody works by blocking a molecule known as CTLA-4 (cytotoxic T-lymphocyte antigen), which may play a role in slowing down or turning off the body’s immune system, according to an agency news release.

Endo has received FDA approval of Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Novartis has received FDA approval of its NDA for its dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not indicated to treat asthma or sudden symptoms of COPD, according to the company. The agency also approved the company’s Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 mcg as a stand-alone monotherapy for the same COPD indication.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome