Spanish biopharmaceutical company PharmaMar has submitted a request for accelerated assessment to the European Medicines Agency (EMA) for its drug lurbinectedin in combination with Roche's Tecentriq (atezolizumab) for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
The company describes the combination therapy as "practice-changing" for patients with this aggressive form of lung cancer. PharmaMar is one of two companies that applied this month for fast-track review of their planned EU marketing applications.
Novel Combination Approach for Aggressive Lung Cancer
Small cell lung cancer accounts for approximately 15% of all lung cancer cases and is characterized by rapid growth and early metastasis. The extensive-stage designation indicates that the cancer has spread beyond the lung to other parts of the body, presenting significant treatment challenges.
Lurbinectedin, marketed as Zepzelca in some markets, is a selective inhibitor of oncogenic transcription. The drug works by binding to DNA, which triggers a cascade of events that can ultimately lead to cancer cell death. Jazz Pharmaceuticals partnered with PharmaMar to develop and commercialize lurbinectedin in certain territories.
Tecentriq (atezolizumab), developed by Roche, is a PD-L1 inhibitor that helps the immune system identify and target cancer cells. The combination of these two mechanisms of action—direct cancer cell targeting and immune system activation—represents a potentially powerful approach to treating ES-SCLC.
Regulatory Strategy and Market Implications
The accelerated assessment procedure is designed to expedite the evaluation of medicines that are of major public health interest, particularly those representing therapeutic innovations. If granted, this status could reduce the EMA's review time from 210 days to 150 days.
"This application represents an important milestone in our commitment to addressing the significant unmet needs of patients with extensive-stage small cell lung cancer," said a PharmaMar spokesperson. "The current treatment landscape for ES-SCLC has seen limited innovation, and patients continue to face poor prognoses."
The company has not publicly disclosed the complete clinical data supporting the application, but the designation as "practice-changing" suggests significant efficacy or safety advantages over current standard-of-care treatments.
Current Treatment Landscape for ES-SCLC
The standard first-line treatment for ES-SCLC typically involves platinum-based chemotherapy, often combined with etoposide. In recent years, the addition of immunotherapy agents to chemotherapy has shown improved outcomes.
If approved, the lurbinectedin-Tecentriq combination would enter a market where few effective second-line options exist. This represents a significant opportunity to address an area of high unmet medical need, as patients with ES-SCLC who progress after first-line therapy have limited treatment options and generally poor outcomes.
Strategic Partnerships
The application highlights the ongoing collaboration between PharmaMar and Jazz Pharmaceuticals. Jazz currently holds commercialization rights for lurbinectedin in certain territories following a licensing agreement valued at up to $1 billion, including upfront and milestone payments.
The inclusion of Roche's Tecentriq in the combination therapy also represents a strategic alignment between these companies in the oncology space, potentially benefiting all parties if the combination proves successful in the marketplace.
Next Steps in the Regulatory Process
The EMA's Committee for Medicinal Products for Human Use (CHMP) will now evaluate PharmaMar's request for accelerated assessment. If granted, the company would then proceed with submitting its formal marketing authorization application for the combination therapy.
Industry analysts will be watching closely for any clinical data releases that might shed light on the efficacy and safety profile of this combination therapy, particularly in comparison to existing treatment options for ES-SCLC.
The outcome of this regulatory process could significantly impact treatment protocols for ES-SCLC patients across Europe, potentially offering new hope for a patient population that has historically had limited effective treatment options.
