ImmunityBio has received FDA approval for its lead drug candidate, Anktiva, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval follows the successful completion of clinical trials that demonstrated a 62% complete response rate and a duration of response of over 47 months. Anktiva is the first-in-class IL-15 agonist immunotherapy to receive FDA approval for NMIBC and represents a significant milestone for ImmunityBio.
Koninklijke Philips (PHG) has received FDA 510(k) approval for its Zenition 30 mobile C-arm, a device that enables image-guided surgical procedures with greater control and image clarity. The device addresses staff shortages and financial constraints in hospitals, improving patient access and reducing waiting periods. The Zenition 30 is designed to provide surgeons with more customization and flexibility, allowing them to focus on patient care amidst a global image guided surgery devices market that is projected to reach $17.2 billion by 2032.
The U.S. Food and Drug Administration (FDA) has approved Novartis’ Lutathera for children 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This marks the first approval of a medicine for children with this type of rare cancer.
ImmunityBio has announced the FDA’s approval of ANKTIVA for treating non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) who have not responded to BCG therapy. This approval marks the company’s transition to a commercial biotech with the potential to generate revenue. Additionally, it unlocks expansion opportunities for ANKTIVA in treating acute myeloid leukemia (AML) and platinum-resistant ovarian cancer (PROC). Despite the risks associated with competition and the need for further clinical trials, the FDA approval and potential expansions present promising investment opportunities.
The FDA has approved ImmunityBio’s Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Anktiva, a first-in-class IL-15 agonist immunotherapy, received FDA Breakthrough Therapy Designation and approval based on its high complete response rate (62%) and long duration of complete response (over 47 months). The approval marks a significant milestone for ImmunityBio and the field of immunotherapy in bladder cancer treatment.
Gene therapy, a groundbreaking medical advancement, offers immense promise for treating genetic disorders. However, the absence of long-term safety data poses challenges. Early evidence-development strategies and cautious early coverage decisions are crucial to ensure the safest and most beneficial outcomes for patients and society.
High blood pressure, or hypertension, affects an estimated 1.3 billion people worldwide and results in 10 million deaths per year. Affecting a person’s whole body and slowly damaging blood cells, hypertension is the number one risk factor for death on a global scale.
