Cancer patients are asked to register PharmaMar’s drug Zepzelka in Russia for the treatment of a rare type of lung cancer

Patients with small cell lung cancer, an aggressive and rapidly progressing disease, are asking the Ministry of Health to register in Russia the “cutting edge” drug Zepzelka from the Spanish company PharmaMar. Almost 40,000 people have already signed the Change.org petition. Oncologists note that this is one of the few new drugs that have appeared in recent years for the treatment of small cell lung cancer, so high hopes are pinned on it. However, the results of the study do not justify them yet, and more accurate ones will not be until 2025. Patients, on the other hand, believe that “all people with cancer, on the entire planet, in any country, have the right to life and access to the possibilities of modern medicine.” The Ministry of Health indicates that they did not receive applications for registration of the drug from the manufacturer.

Small cell lung cancer is one of the most intractable types of disease; it is a malignant tumor with an aggressive clinical course and widespread metastasis. This form accounts for 20-25% of all types of lung cancer. Patients wrote a petition to the Ministry of Health, asking for registration in Russia of a new “cutting edge” drug for the treatment of this form of cancer – lurbinectin (zepzelka) by the Spanish PharmaMar. Almost 40,000 people joined the campaign on Change.org within a week. Activists also asked the manufacturer to pay attention to them.

The petition emphasizes that zepzelka is approved by the FDA (the American analogue of Roszdravnadzor) and is included in the recommendations of the National Comprehensive Cancer Network (NCCN, USA), is included in clinical recommendations in Canada, the UK, Brazil and other countries: “It is impossible to get it in Russia right now – it is not registered, although it has been repeatedly mentioned in articles, interviews and broadcasts by Russian oncologists who are very interested in its use, but do not yet have the opportunity to prescribe this effective treatment to their patients.

Cancer epidemiologist Anton Barchuk points out that Zepzelka is one of the few new drugs that have appeared in recent years for the treatment of small cell lung cancer, so great hopes are pinned on it. This is a second line drug. It is prescribed when the first stage of treatment – radiation therapy, immunotherapy and chemotherapy – have stopped working. That is why it was approved in the US and Europe in 2019-2020 based on the results of a preliminary study. “However, a later large study showed that the drug is not as effective as standard therapy in terms of improving overall patient survival as expected,” says Mr. Barchuk.

Head of the Department of Antitumor Drug Treatment of the National Medical Research Center for Radiology of the Ministry of Health of Russia, Doctor of Medical Sciences Natalya Falaleeva, clarifies that lurbinectedin monotherapy has demonstrated efficacy as a second-line therapy with an objective response rate of 35.2% (22.2% in platinum-resistant and 45% in those sensitive to platinum patients), a mean duration of response of 5.3 months, and a manageable safety profile. The median overall survival was 9.3 months. A phase III randomized trial published in January 2023 in the Lancet, however, did not show a global improvement in treatment outcomes.

Anton Barchuk notes that the American NCCN even downgraded the status of the drug after that: it moved from the priority category to the category of “one of many other recommended methods”. “It’s a big plus that another drug has appeared for the treatment of small cell cancer, since there are, in principle, few of them. But this is not yet the drug that will change the rules of the game. So far, studies do not talk about this, and new results will not be available until 2025,” continues Mr. Barchuk. “Unfortunately, if we are talking about the second line of therapy for small cell lung cancer, especially if the first one was ineffective, then the prognosis for these patients is really extremely poor . As a rule, they quickly have a relapse of the disease, regardless of the treatment option, and there is very little time left. Small cell lung cancer remains one of the most aggressive malignant diseases.”

The author of the petition, Maya Khaustova, refers to the words of Irina Tverezovskaya, an oncologist-chemotherapist at the De Vita Cancer Center. In March, a doctor, live on YouTube, answered questions from patients with small cell lung cancer and stated that Zepzelka is more effective than another second-line drug – topotecan – for “organ foci”, “penetrates into the brain” better and has “not the same spectrum of toxicity” . A plus, according to Mrs. Tverezovskaya, is that it needs to be administered three times a week, while the closest analogue is five. Maya Khaustova believes “that all people with cancer, on the entire planet, in any country, have the right to life and access to the possibilities of modern medicine, as mentioned in Article 25 of the UN Universal Declaration of Human Rights.”

Nikolai Bespalov, Development Director at RNC Pharma, says that earlier there were not rare cases when innovative drugs appeared in Russia at the same time as in other countries. However, in the current conditions, when conducting clinical trials in our country is difficult due to sanctions (and this is the main condition for drug registration in the Russian Federation), the process may be slowed down. “It’s hard to say what will happen with this drug. Since we are talking about drugs that are purchased at the expense of the state budget, in any case, it will be necessary to follow the official procedure, and the launch of this procedure is hardly possible due to only such public activity. Here, the participation of the manufacturing company is needed, and, possibly, the intervention of representatives of the Ministry of Health in order to formalize the need for such a product,” Bespalov believes.

The Ministry of Health of Russia told Kommersant that the registration of medicines for circulation in the Russian Federation is carried out exclusively at the initiative of the manufacturer. “A drug with the trade name Zepzelka is currently not registered in the Russian Federation, and no applications for registration have been received from its manufacturer,” the press service said.

“Kommersant” sent a request to PharmaMar, but at the time of publication did not receive a response.

Natalia Kostarnova