Zepzelca, PharmaMar’s treatment for small cell lung cancer, remains out of reach for European patients as regulatory and reimbursement processes drag on. Despite proven benefits and US approval, the drug’s future in Spain depends on government action and industry support.
PharmaMar’s cancer drug Zepzelca has cleared a major hurdle in Europe. The European Commission now officially allows the use of Zepzelca (lurbinectedin) with atezolizumab as first-line maintenance therapy for adults with extensive-stage small cell lung cancer (SCLC) who have not progressed after induction therapy. This is more than a paperwork step. It moves Zepzelca past the old waiting stage and into the list of approved treatments.
But the story is far from over. Luis Mora, director general of PharmaMar’s Oncology Business Unit, did not hide 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. In Europe, patients and doctors are still waiting. The European Commission’s green light is not enough. Each country must still decide if it will pay for the drug. That can take months, or even longer.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved the Zepzelca and atezolizumab combination for the same indication, highlighting the drug’s international regulatory momentum.
In Spain, PharmaMar is pushing for approval from the Ministry of Health. The company wants Zepzelca included in the National Health System’s reimbursement list. Mora said, “We have reached a funding proposal that I consider optimal. It is important to recognize the value of this medicine, which is what will be financed.” Official sources confirm the process is still open. The Ministry of Health has not made a final decision about Zepzelca’s place in the system.
The numbers behind Zepzelca are clear. 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. These results come from the IMforte study. Independent sources confirm the study compared lurbinectedin plus atezolizumab to atezolizumab alone in maintenance therapy. The European Commission based its approval on these findings. Patients with extensive-stage SCLC who did not progress after initial treatment saw real benefit.
PharmaMar also points to the bigger picture. The company employs more than 450 people. It invests in clinical trials and exports up to 95% of its production. That brings 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. The Haute Autorité de Santé in France 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. This original indication differs from the more recent European approval for first-line maintenance therapy in combination with atezolizumab.
The real problem is not science. It 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 reality, delays are common. Mora urged the next government to focus on science, research, and industry. He warned that Europe’s reliance on outside supply chains is risky. Regulatory analysts say the EMA led the European application, but each country’s reimbursement process is a separate fight.
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 key. Many promising companies vanish or get bought before their products reach the market. The reason is simple. They lack experienced developers and money.
PharmaMar is not waiting around. The company is moving forward with new projects. PM54 is showing early promise. Other compounds are set to enter clinical phases between 2027 and 2028. For lurbinectedin, PharmaMar is waiting for results from a trial as a first-line treatment for a subtype of sarcoma that makes up about 30% of all sarcomas. Results are expected this spring.
Spain has the science and the industry. But the gap between discovery and delivery is still wide. Zepzelca’s fate in Europe will show if policymakers are ready to turn talk about innovation into real action. For now, the lesson is blunt. Without faster, more practical ways to get drugs to patients, even the best breakthroughs can get stuck in bureaucracy.
