New Treatment Approval for Rare Genetic Disorder Tops SPT Week in Review

5. Triple Combo Therapy Shows Potential as First-line Treatment in Stage 4 NSCLC

The addition of durvalumab (Imfinzi, AstraZeneca) and tremelimumab to chemotherapy improved progression-free survival (PFS) in patients with previously-untreated stage 4 non-small cell lung cancer (NSCLC). Read more.

4. FDA Approves Biosimilar for Multiple Inflammatory Conditions

Officials from the FDA have approved adalimumab-afzb (Abrilada, Pfizer) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Read more.

3. Abrocitinib Leads to Higher Skin Clearance, Itch Relief in Atopic Dermatitis

Abrocitinib led to a higher skin clearance as well as itch relief compared with a placebo in patients aged 12 years and older with moderate to severe atopic dermatitis (AD), according to a phase 3, 12-week, pivotal study called JADE MONO-1. Read more.

2. FDA Approves Acalabrutinib for CLL Indication

As part of a new international collaboration, officials with the FDA today granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia. Read more.

1. FDA Approves Givosiran for Adult Patients with Acute Hepatic PorphyriaThe FDA has approved givosiran (Givlaari, Alnylam Pharmaceuticals) for adult patients with acute hepatic porphyria (AHP), a genetic disorder resulting in the buildup of toxic porphyrin molecules formed during the production of heme, which binds oxygen in the blood. Read more.