Sotorasib, the drug that can cure cancer stopped by bureaucracy

“Who decides who gets to live?”. Sara confides this to us with her voice cracking with concern for her 70-year-old father. Since last November, her family has been living with the sword of Damocles of …

Sotorasib, the drug that can cure cancer stopped by bureaucracy

“Who decides who gets to live?”. Sara confides this to us with her voice cracking with concern for her 70-year-old father. Since last November, her family has been living with the sword of Damocles of a diagnosis confirmed by two oncologists, the first in Trento and the second in Milan: lung adenocarcinoma, the most common among malignant lung tumors. A subtle disease, which initially presents without serious symptoms, at least in appearance. Crazy epithelial cells that proliferate in the lung tissues in an uncontrolled manner. It begins with a dry, long-lasting cough, then the breathlessness and weakness that takes over the body as the disease progresses.

Anyone who has lived with cancer is aware that survival is linked to the speed with which treatment is undertaken. It is necessary to avoid that the tumor reaches stage IV and that, leaving the diseased organ, the metastases travel around the body. So the so-called first line therapy begins immediately, the standard one which involves chemotherapy and immunotherapy. But during the diagnostic tests the molecular analysis conducted in Verona after the PET and CT scan revealed a peculiarity. The patient tested positive for a genetic mutation called KRAS G12C. The K-Ras protein is involved in the control of cell proliferation processes and, if mutated, remains perpetually in an active state determining the growth of tumor cells. In practice the proliferation of the tumor.

What at first glance may appear to be a complicated digression is actually important because it makes the whole story surreal. KRAS gene mutations are seen in approximately 30% of cases diagnosed with adenocarcinoma and is typically seen in nonsmokers. What does it mean? Anyone who, in the absence of other risk factors, develops lung cancer is probably due to this gene that drives the cells crazy. Not only that: there would be a cure.

Sotorasib, the cancer drug that cannot be found in Italy

In 2021, two drugs that inhibit the effects of the mutation obtained initial recognition by the Food and drug administration, the US government agency that regulates pharmaceutical products. These are sotorasib and adagrasib, drugs that have the ability not only to stabilize the disease, but also to make it regress.

According to data from the largest clinical trial conducted to date, tumor shrinkage was recorded in 36 percent of patients treated with sotorasib, but in 81 percent of cases it facilitated disease control despite the patients who participated in the study had aggressive tumors already in advanced stages. Adagrasib would demonstrate even more promising results in the first trials, but still to be validated with a phase III study. In short, sotorasib represented hope for combating such a frequent and deadly mutation considered unassailable by drugs on the market. But if the drug defined as a cornerstone of oncology exists, it is impossible to find it in Italy.

As Dea Anna Gatta, president of the non-profit association Alcase Italia which legally helps cancer patients, explains to us, the drug is used practically throughout Europe, while in Italy the procedure requires that after the oncological diagnosis a first line of treatment is provided ” standard” with chemotherapy drugs and/or immunotherapy, only in the second line can a treatment with a molecular drug such as sotorasib be proposed.

“The oncologist told us clearly, forget the sotorasib” the daughter of a patient being treated in Trento tells “Yet all you have to do is go to Germany and it is available, but also in Rome, just beyond the walls of the Vatican City. A hope of treatment so close, but which is denied to patients” denounces the woman who launched an online appeal on Change. org collecting almost 50 thousand signatures. “I’m ready to go and buy it in Germany, but who can afford to pay 4 thousand euros a month for the treatment (the initial dose is 8 pills a day, 960 mg of the drug, ed.)”.

sotorasib petition

But why, if there is a drug that can help combat the disease (guaranteeing 33 percent survival two years after diagnosis) is it not available in our country? To clarify, we asked the Italian Medicines Agency (Aifa) and Amgen Pharmaceutical for information, which requested authorization to market sotorasib under the trade name of Lumykras. So let’s start by taking a step back.

After the positive opinion of the European agency (EMA), on 6 January 2022 the European Commission authorized the use of the drug. In Italy it is currently possible to obtain sotorasib only through access to a nominal use program. According to Amgen, the pharmaceutical company submitted the request for reimbursement to AIFA immediately after approval by EMA.

The authorization granted to Lumykras, the trade name of Sotarasib

“The reimbursement procedure required an extension of time due to the regulatory body’s need to evaluate further data from the phase III CodeBreak 200 study, still underway at the time of the reimbursement request” explain the pharmaceutical company. According to what we understand, this request occurred on March 31, 2023.

“Amgen provided all the requested evidence as soon as it was available in order to quickly continue the negotiation process” the pharmaceutical company explains to which assures that the approval process with Aifa is in its final stages.

The cancer drug stopped by bureaucracy

As Amgen reminds us, sotorasib has been available in Italy in CNN class since March 2023 and hospitals can purchase it privately. This is a procedure intended for drugs already approved by the EMA, but not yet negotiated by the Italian Medicines Agency for the purposes of reimbursement by the National Health Service. Therefore they can only be supplied by hospitals if the competent regional commission has approved their use. A distortion of the conversion into law of the Balduzzi Decree which instead provided for the immediate placing of the medicine on the market, thus avoiding delays which often cause national and/or community legal disputes.

The same law – as stated in this Aifa document – provided for the deadline for concluding the price negotiation procedure from the marketing data to be 180 days. The drug agency contacted about the case had not responded at the time of this article’s publication.

Because the new appointments at AIFA are causing discussion

“To protect the interests of patients, Amgen is confident of quickly completing the reimbursement process for sotorasib – the pharmaceutical company explains – if the hospital where the patient is being treated needs any information or makes special requests , you can contact us at the following address: [email protected]”.

“It is absurd that a drug is available but cannot be used in hospitals due to bureaucratic delays” Sara tells “People who need it cannot wait, who decides who can live? A patient from Reggio Emilia came to missing a few days ago, when the drug is available she will no longer be there.”