The European Commission has authorized Zepzelca (lurbinectedin) with atezolizumab as first-line maintenance therapy for adults with extensive-stage small cell lung cancer (SCLC) whose disease has not progressed after induction therapy. The decision adds Zepzelca to Europe’s list of approved treatments, but does not guarantee patient access.
Access remains uncertain. Luis Mora, director general of PharmaMar’s Oncology Business Unit, voiced his frustration at the VII Simposio del Observatorio de la Sanidad de EL ESPAÑOL-Invertia. “We are in processes of access to the market in the European Union, which everyone knows are not exactly agile,” he said. Zepzelca is already available in the US and other countries, while patients and doctors in Europe are still waiting. European Commission approval alone is not enough: each country must decide whether to pay for the drug, a process that can take months or longer. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved the Zepzelca and atezolizumab combination for the same indication.
In Spain, PharmaMar is seeking approval from the Ministry of Health to add Zepzelca to the National Health System’s reimbursement list. Mora said, “We have reached a funding proposal that I consider optimal. It is impressive to recognize the value of this medicine, which is what will be financed.” Official sources say the process remains open, and the Ministry of Health has yet to make a final decision on Zepzelca’s place in the system.
PharmaMar says the drug cuts the risk of death or disease progression by 46% in maintenance therapy for small cell lung cancer. It also reduces the risk of death by 27%, based on overall survival. The results come from the IMforte study, which compared lurbinectedin plus atezolizumab with atezolizumab alone in maintenance therapy. The European Commission based its approval on the findings. Patients with extensive-stage SCLC whose disease did not progress after initial treatment saw a benefit.
PharmaMar also points to its wider economic contribution. The company employs more than 450 people and invests in clinical trials; it also exports up to 95% of its production, bringing tax revenue and foreign currency into Spain. “If you look at the fiscal balance, it is worth it if our value is recognized,” Mora said. He praised Spain’s strong clinical trial and hospital network. But approval does not always mean access. France’s Haute Autorité de Santé has denied early access or reimbursement for Zepzelca in combination with atezolizumab for patients without CNS metastases. National health authorities can still say no.
In the United States, Zepzelca initially received accelerated approval from the FDA in June 2020 for adults with metastatic small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. That indication differs from the more recent European approval for first-line maintenance therapy in combination with atezolizumab.
The challenge is getting the drug to patients. PharmaMar’s clinical development is strong, but the path from lab to pharmacy is slow. Spanish law sets a 180-day target for market access to new medicines; in practice, delays are common. Mora urged the next government to put science at the center of policy, with research and industry in focus. He warned that Europe’s reliance on outside supply chains is risky. Regulatory analysts say the EMA led the European application, while each country’s reimbursement process remains a separate hurdle.
Mora put it plainly: “Even with excellent scientists, what matters is having good developers within a company. That is the figure Spain needs to strengthen, because there are not many.” He also said capital is basic. Many promising companies disappear or are bought before their products reach the market because they lack experienced developers and money.
PharmaMar is advancing new projects. PM54 is showing early promise, while other compounds are set to enter clinical phases between 2027 and 2028. For lurbinectedin, the company is awaiting results from a trial testing the drug as a first-line treatment for a sarcoma subtype that accounts for about 30% of all sarcomas. Results are expected this spring.
