On August 11, 2014 Bayer HealthCare reported that EYLEA (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema (DME) (Press release Bayer, AUG 11, 2014, View Source [SID:1234500692]). Bayer plans for an immediate roll-out with Germany being one of the first launch countries in Europe.

“The approval of EYLEA in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DME,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions.”

“The results of two phase 3 studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection,” said Prof. Jean-Francois Korobelnik, Principal Investigator of the VIVID-DME trial and Chief of Ophthalmology, CHU Bordeaux. “Early diagnosis of DME is critical, and if not treated rigorously, there is a high risk of DME leading to blindness.”

EYLEA has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales

On August 11, 2014 Millennium (Takeda) reported that the U.S. Food and Drug Administration (FDA) has approved VELCADE (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment (Press release Takeda, AUG 10, 2014, View Source [SID:1234500700]). The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in combination with dexamethasone in patients previously treated with VELCADE. VELCADE retreatment may be started at the last tolerated dose.

The approved retreatment sNDA consisted of a Phase 2 study and other supportive data. The Phase 2 international RETRIEVE trial showed a 38.5 percent overall response rate (ORR) in multiple myeloma patients who had been previously treated with a VELCADE-based regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with VELCADE retreatment was consistent with the known safety profile of intravenous VELCADE in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment. The most common adverse drug reaction was thrombocytopenia, which occurred in 52 percent of the patients.

“For the past 11 years, VELCADE has played an important role as the only therapy proven to extend overall survival for patients with newly diagnosed and relapsed multiple myeloma,” said Michael Vasconcelles, MD, Global Head, Oncology Therapeutic Area Unit, Takeda. “With these newly approved dosing guidelines, physicians will be able to provide their patients, who have previously received VELCADE, with an effective treatment extending VELCADE use across the continuum of care of multiple myeloma.”

RETRIEVE was a single arm, open-label trial. The study enrolled 130 patients ages 18 years and older who had previously responded to VELCADE-based therapy and relapsed at least six months after prior treatment with VELCADE. The study met its primary endpoint of best confirmed response to retreatment as assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria.

* Patients had received a median of two prior therapies (range of 1-7).

* Dexamethasone was administered in combination with VELCADE in 94 patients.

* Of the 130 patients, one patient achieved complete response and 49 achieved partial response (50/130; ORR 38.5 percent).

* In the 50 responding patients, the median duration of response was 6.5 months (range of 0.6 to 19.3 months).
The incidence of grade ≥3 thrombocytopenia was 24 percent. Peripheral neuropathy occurred in 28 percent of patients, with the incidence of grade ≥3 peripheral neuropathy reported at 6 percent. The incidence of serious adverse reactions was 12.3 percent; the most commonly reported serious adverse reactions were thrombocytopenia (3.8 percent), diarrhea (2.3 percent), herpes zoster and pneumonia (1.5 percent each). Adverse reactions leading to discontinuation occurred in 13 percent of patients.