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Monthly News Roundup - March 2018

FDA OKs First-In-Class HIV Drug Trogarzo for Drug Resistant HIV

The FDA has approved a novel HIV agent for patients who have multidrug-resistant HIV (MDR HIV-1) and have failed other therapies. Trogarzo (ibalizumab-uiyk) from TaiMed Biologics is the first monoclonal antibody approved for the treatment of MDR HIV-1 infection. Trogarzo binds to CD4+ receptors on host cells and blocks the HIV virus. In one study, 40 MDR HIV-1 patients with high HIV virus levels who had already received multiple other HIV treatments were evaluated. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43% of the trial’s participants achieved HIV RNA suppression. Diarrhea, dizziness, nausea and rash were commonly reported side effects.

FDA Approves Sun Pharma’s Ilumya for Plaque Psoriasis

Psoriasis is a non-contagious skin condition with redness, itching, and thick, dry scales. This month the FDA cleared Ilumya (tildrakizumab-asmn), an interleukin-23 antagonist, for moderate-to-severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. In two Phase III studies, 926 patients received Ilumya or placebo. The primary efficacy endpoints, defined as at least 75% of skin clearance and Physician's Global Assessment score of "clear" or "minimal" at week 12 after two doses, were met in both studies. Ilumya is given as a 100 mg subcutaneous (under the skin) injection every 12 weeks, after initial 100 mg doses at weeks 0 and 4.

Latuda Gains New Indication for Bipolar Depression Treatment in Pediatrics

Sunovion’s Latuda (lurasidone), an antipsychotic agent, has gained a new indication for treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in pediatric patients ages 10 to 17 years. Latuda is the first single-agent formulation to receive FDA approval for pediatric bipolar depression. In a 6-week study, 347 patients 10 to 17 years old received Latuda flexible dosing once-a-day (20 to 80 mg) or placebo. The primary endpoint, change from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) total score, was met when compared to placebo. The most common side effects included nausea, weight gain, and insomnia.

Adcetris Use Expanded as First-Line Agent in Advanced Hodgkin Lymphoma

The FDA has approved Adcetris (brentuximab vedotin) plus chemotherapy to treat adults with previously untreated stage III or IV classical Hodgkin lymphoma. Adcetris, from Seattle Genetics, is combined with an antibody that directs the drug to the CD30 lymphoma target. In the phase 3 clinical trial of 1,334 patients, Adcetris + chemotherapy (doxorubicin, vinblastine, and dacarbazine [AVD]) was compared to AVD + bleomycin (ABVD). The primary endpoint, modified progression-free survival (mPFS) measured disease progression, time to death, or time to new therapy. The Adcetris plus AVD group was 23% less likely to experience progression, death, or initiation of new therapy compared with those receiving ABVD.

Opdivo: The First PD-1 Inhibitor to Offer Every Four-Week Dosing

This week Bristol Myers Squibb announced new approvals for Opdivo (nivolumab) dosing schedules and infusion times. Opdivo, originally approved in 2014 to treat advanced melanoma, is an immune checkpoint inhibitor that blocks the PD-1 receptor to activate the immune system to fight cancer. The newly approved Opdivo dose is 480 mg every 4 weeks, in addition to the previous 240 mg every two weeks dose. The every 4 week dose can be used in multiple cancer types, including melanoma, liver, lung, kidney, bladder, head and neck, and Hodgkin lymphoma. Opdivo also was approved for a shorter 30-minute infusion across all approved indications.

Posted: March 2018