New Hope for Advanced Skin Cancer as UNLOXCYT™ Enters US Market

LOUISVILLE, KY – January 16, 2026 – Patients battling advanced forms of a common skin cancer have been granted a significant new therapeutic option with the recent market entry of UNLOXCYT™ (cosibelimab-ipdl). To ensure this vital medication reaches those in need, developer Sun Pharmaceuticals has named Onco360®, the nation's largest independent oncology pharmacy, as its national pharmacy partner. This collaboration is set to streamline access to the first and only PD-L1 immune checkpoint inhibitor approved for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC/laCSCC) who are ineligible for curative surgery or radiation.

Cutaneous squamous cell carcinoma (CSCC) is the second most prevalent form of skin cancer, with an estimated 1 million cases treated annually in the United States alone. While the majority of cases are localized and successfully treated, a subset of patients develops advanced disease where the cancer spreads or becomes too extensive for traditional treatments. For this population, the outlook has historically been grim. The five-year survival rate for metastatic CSCC can drop below 50%, with some studies reporting mortality rates exceeding 70%.

“Onco360 is proud to be chosen as the specialty pharmacy partner for UNLOXCYT,” said Benito Fernandez, Chief Commercial Officer at Onco360, in a statement. “As the first and only treatment option for adults with metastatic or locally advanced cutaneous squamous cell carcinoma, this therapy is a meaningful option for patients who have limited alternatives. We are committed to providing exceptional comprehensive support services and seamless access for UNLOXCYT patients and their providers.”

An Evolution in Checkpoint Inhibition

UNLOXCYT™ represents a critical advancement in immunotherapy, a field that harnesses the body's own immune system to fight cancer. It functions as a PD-L1 blocking antibody. In some cancers, tumor cells express the PD-L1 protein on their surface, which acts as a 'stop sign' for immune cells, particularly T-cells, preventing them from attacking the tumor. UNLOXCYT™ works by binding to PD-L1 and blocking this interaction, effectively releasing the brakes on the immune system and allowing it to recognize and destroy cancer cells.

The drug's approval by the U.S. Food and Drug Administration on December 13, 2024, was supported by compelling data from the pivotal CK-301-101 clinical trial. The study demonstrated significant and durable clinical responses in patients with advanced CSCC. Among patients with metastatic disease, 47% achieved an objective response, meaning their tumors shrank or disappeared. Similarly, 48% of patients with locally advanced disease experienced an objective response. Crucially, these responses were lasting; at the time of analysis, the median duration of response had not yet been reached for the metastatic patient group, with responses ongoing in approximately 73% of those patients.

The therapy was also found to have a manageable tolerability profile, a key consideration for this often-frail patient population. The most common adverse reactions included fatigue, musculoskeletal pain, rash, and diarrhea. This combination of durable efficacy and proven tolerability positions UNLOXCYT™ as a transformative option for patients who previously faced a therapeutic void.

The Strategic Role of a Specialty Pharmacy

The successful launch of a highly specialized, high-cost oncology drug like UNLOXCYT™ hinges on more than just its clinical efficacy; it requires a sophisticated distribution and support network. This is where the partnership with Onco360 becomes indispensable. Unlike traditional retail pharmacies, specialty pharmacies are designed to manage the complexities associated with advanced medications.

Onco360 provides a high-touch, patient-centric model that addresses the primary barriers to care. Their services extend far beyond dispensing medication. The pharmacy's clinical teams, which include pharmacists, registered nurses, and case managers, work directly with patients and their healthcare providers to manage the entire treatment journey. This includes navigating the often-convoluted prior authorization process with insurance companies to prevent treatment delays.

Furthermore, financial toxicity is a major concern with novel cancer therapies. Onco360 actively helps patients mitigate these costs by connecting them with financial assistance programs, including manufacturer co-pay support and grants from charitable foundations. Sun Pharma has established its own program, UNLOXCYT SUPPORT™, to provide a dedicated resource for patients and providers, a service that Onco360 will help facilitate. This comprehensive support system, which also includes patient education on side-effect management and programs to ensure medication adherence, is critical for optimizing treatment outcomes.

Reshaping the Treatment and Market Landscape

The arrival of UNLOXCYT™ and the strategic partnership for its distribution carry significant implications for the oncology market. For Sun Pharmaceuticals, a global pharmaceutical giant, the successful launch strengthens its footprint in the competitive U.S. oncology space by bringing a first-in-class therapy to a patient population with a clear and pressing unmet need. It demonstrates a strategic focus on developing innovative treatments that can make a tangible difference in patient lives.

For Onco360, a flagship brand of PharMerica Corporation, being selected as the national partner for UNLOXCYT™ reinforces its position as a leader in the specialty pharmacy sector. The partnership aligns perfectly with its business model of providing specialized, end-to-end support for complex oncology treatments, showcasing its value to pharmaceutical manufacturers looking to ensure their innovations reach the market effectively.

For patients and oncologists, the availability of UNLOXCYT™ reshapes the standard of care for advanced CSCC. It provides a powerful new tool for a difficult-to-treat cancer, offering the potential for durable responses where options were once severely limited. The collaboration between Sun Pharmaceuticals and Onco360 aims to ensure this promising therapy reaches the vulnerable patients who need it most, marking a pivotal moment in the management of advanced cutaneous squamous cell carcinoma.