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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-80/
- Published: 2016-06-05T12:00:00.000Z
- Updated: 2026-09-14T21:07:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135846

**Novartis Pharmaceuticals** and **Eisai** will collaborate on commercial and certain medical affairs activities in the U.S. to co-promote Lenvima (lenvatinib) capsules in combination with Novartis’ Afinitor (everolimus) for treating patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. The two companies say that they will promote the availability of this combination regimen to appropriate healthcare professionals nationwide, and participate in certain joint medical affairs activities to facilitate the appropriate medical use of and medical education on the combination.

**Stealth BioTherapeutics** reported positive results from MMPOWER, a Phase 2 trial placebo-controlled study to evaluate the safety, tolerability and efficacy of the systemic delivery of elamipretide for treating primary mitochondrial myopathy, or muscle weakness, in patients with a genetically confirmed mitochondrial disease. FDA granted fast-track designation to the company for this indication in January.

The **American Academy of Ophthalmology** says it plans to launch a new scientific journal, the *Ophthalmology Retina* journal, focused exclusively on retina-related eye diseases and conditions. The academy says the journal will publish original research that will be of strong interest to retina specialists globally. It adds that the new, print and on-line publication will be an extension of *Ophthalmology,* the journal of the American Academy of Ophthalmology.

**Aytu BioScience** has begun enrollment and patient dosing in its prostate cancer study, detecting and localizing carcinoma using high resolution transrectal gamma imaging (TRGI), in collaboration with **Hybridyne Imaging Technologies** to investigate the efficacy of Hybridyne’s ProxiScan compact gamma cameras to detect local prostate cancer using Aytu’s imaging agent ProstaScint. The companies say the study at Princess Margaret Cancer Centre in Canada will enroll about 60 men of three groups: patients who have rising levels of PSA (>0.05ng/ml) after radical prostatectomy treatment; patients who have rising PSA (>10ng/ml) and/or abnormal digital rectal exam and have previously undergone at least one prostate biopsy that was determined to be negative for prostate cancer; and patients diagnosed with prostate cancer (with at least one positive prostate biopsy) and have a scheduled biopsy as part of their routine follow-up.

**Celator Pharmaceuticals** says its Phase 3 trial of Vyxeos (cytarabine: daunorubicin) Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia met its primary endpoint demonstrating a statistically significant improvement in overall survival. The trial compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3\. The company says the median overall survival for patients treated with Vyxeos was 9.56 months compared to 5.95 months for patients receiving 7+3.

**Novartis** presented data at the 52nd Annual Meeting of the American Society of Clinical Oncology in Chicago from a Phase 3 study that showed a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to Tafinlar monotherapy. According to the company, results from the COMBI-d study of 423 patients found the estimated three-year survival rate to be 44% for patients receiving the combination of Tafinlar + Mekinist compared with 32% who received Tafinlar alone.