In August of 2021, Medebound HEALTH received a lung cancer patient from East Asia. A seasoned doctor from Memorial Sloan Kettering Cancer Center provided guidance on the next best treatment plans. After the second opinion consultation, we successfully helped the patient obtain a new drug through our Named Patient Access process for pharmaceutical medicines.
The following is a brief summary of the patient’s situation.
Case Brief
The patient is a 60-year-old female, currently diagnosed with a right pleural malignant nodule, right lung cancer after surgery.
In September 2015, the patient found a right lung nodule, about 1.0×1.5cm in size, and underwent thoracotomy for right middle lobectomy on September 30, 2015. The postoperative pathological results were right middle lobe invasive adenocarcinoma. No cancer metastasis was found in the lymph nodes in groups 7, 10, and 11.
After the operation, the patient was followed regularly. On May 11, 2021, the patient’s chest CT showed the right pleura and interlobular pleural nodules.
The patient underwent a needle biopsy on June 17, 2021, and the results suggested that adenocarcinoma was found. Genetic examination revealed EGFR mutation and insertion of exon 20.
The most important thing the patient wants to know is the most suitable treatment method, as well as whether the treatment method recommended by the local physician is suitable for her specific current condition.
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center from the New York City, is the oldest and largest private cancer center in the world. For over one hundred years, it has been committed to patient care, research innovation, and better understanding, diagnosis, and treatment of cancer. Memorial Sloan Kettering Cancer Center is one of the first cancer centers to receive the Comprehensive Cancer Center designation from the National Cancer Institute.
Memorial Sloan Kettering Cancer Center (MSKCC) has focused on cancer for over a century, founded in 1884. The doctors in the hospital have unparalleled skills in diagnosing and treating various cancers and using the most advanced and innovative methods to increase the possibility of a cure. The close cooperation between doctors and researchers has enabled new drugs and treatments to be put into clinical use faster and provided patients with advanced treatment technologies.
MEDEBOUND HEALTH and the patient’s family collaborated to collect and sort the patient’s medical history data. Professional, on-staff MDs translated the medical history and summarized and extracted relevant key information. The chair of the MSKCC oncology department gave the following reply as soon as he received the patient’s information.
Question: If she were your patient, what plan would you recommend, and how would the medication be used? If the first-line treatment is resistant or the disease progresses, what is the second-line treatment plan? Is Amivantamab-vmjw (JNJ-6372 ) the first choice or the second-line treatment?
Answer: I agree to use high-dose osimertinib in this case; the drug is generally well-tolerated and may effectively control the disease. However, it cannot cure the disease; basically, all cancers of this type are resistant to first-line tyrosinase inhibitor therapy.
Amivantamab-vmjw is currently only approved for the treatment of patients whose condition has deteriorated after receiving platinum-based chemotherapy. Therefore, if the patient’s disease develops resistance to osimertinib, I would consider chemotherapy combined with immunotherapy (such as carboplatin, pemetrexed, and pembrolizumab) as a reasonable next step. The chance of a lasting tumor immune response is not particularly high, but if there is an immune response, it may be sustained and effective. If needed, this will also enable Amivantamab as a third-line option.
On May 21, 2021, the FDA officially approved Rybrevant (amivantamab-vmjw) for use in adult patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. This is the first targeted therapy for lung cancer patients with EGFR exon 20 insertion mutation. It is a major advancement in the medical field for these patients, and it is of milestone significance!
Named Patient Access
After some internal discussions, the patient and his family filed an application to use the new drug Amivantamab-vmjw, which has only been on the US market for a few months in the United States. Medebound HEALTH immediately assisted the patient with this need through a process called Named Patient Access by filing all the legal documentation, managing pharmacy outreach, arranging cold-chain shipping and customs clearance, and other logistics. It took just over one week for the patient to buy new cancer medicine that otherwise would have to wait for years. The patients and their families are very grateful for the help.
For a patient who is running out of hope, waiting for a drug to be approved can be interminable. Some patients with life-threatening diseases cannot afford to wait.
To satisfy an influx of unsolicited patient requests from patients outside the US and to make its FDA-approved product available to patients in countries where it is not licensed, we set up a Named Patient Access program for patients with this need. In almost all countries, any patient (the Named Patient) with a life-threatening, long-lasting, or seriously debilitating illness has the right to access and purchase medicines outside his or her own country that are potentially life-saving or able to improve quality of life. Every country has its own specific rules and regulations surrounding the access and import of innovative medications, and there are many different programs and regulations set up for this purpose. These include the Named Patient Import for a small amount that is only for personal use purposes.
With the development of technology and communication, emerging medical technologies are no longer out of reach, the opinions of the world’s top doctors are at your fingertips, and the newly approved drugs in the world can also be obtained in time. In this era of information interconnectivity, patients don’t need to travel abroad to get diagnosis and treatment and obtain new therapeutic drugs on the spot; they can consult a US-based doctor online. They can still enjoy the latest frontier of medical research and development and obtain new opportunities for survival. MEDEBOUND HEALTH is on the mission to provide quality care in the patients’ home countries.
To learn more about our Named Patient Access, please visit https://www.medeboundhealth.com/pharma.
