#Japan #Tokyo #NSCLC #EGFR Mutation #Amivantamab

Johnson & Johnson's Amivantamab Injection Approved

Johnson & Johnson, known in Japan as Janssen Pharma, has recently secured manufacturing and marketing authorization for its subcutaneous formulation of amivantamab, branded as Librovafz®. This development represents a key advancement for patients diagnosed with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), particularly those with inoperable disease.

The authorization was based on the results of two pivotal international clinical trials: the PALOMA-3 and PALOMA-2 studies. These trials demonstrated that Librovafz® provides consistent therapeutic effects while significantly reducing administration time from hours to minutes and minimizing infusion reactions by as much as 80%. This is particularly noteworthy given that infusion reactions can greatly impact patient comfort and adherence to treatment.

Amivantamab is now the first and only subcutaneous solution approved in Japan for this condition, which accounts for approximately 35-40% of all NSCLC cases. The trials revealed a retention of efficacy similar to the intravenous formulation, Livrebant®, which is used in combination with Laziclus® (generic name: lazertinib).

Clinical Efficacy and Trial Details

In the PALOMA-3 trial, patients with advanced or recurrent NSCLC and EGFR exon 19 deletions or L858R mutations received a combination of amivantamab via subcutaneous injection and lazertinib. This combination was shown to be non-inferior regarding pharmacokinetics compared to the intravenous counterpart. Specifically, the initial administration of amivantamab was reduced dramatically from five hours over two days to just five minutes on the first day, improving patient experience significantly.

Furthermore, only 13% of participants receiving the subcutaneous formulation experienced infusion reactions as opposed to 66% in the intravenous group.

In the PALOMA-2 study, which focused on a similar population but specifically targeted those without prior chemotherapy, the overall response rate was confirmed at an impressive 76%. These results were corroborated by separate trials indicating response rates of 77% among those correctly diagnosed with the correct EGFR mutations. Such significant findings highlight the promise of Librovafz® as a preferred treatment option in clinical oncology, especially in Japan where available treatment choices may be limited for this patient demographic.

The Importance of Innovation in Lung Cancer Treatment

Lung cancer remains one of the most prevalent and deadly cancers globally, with NSCLC making up the majority of cases. The EGFR gene mutation is among the most common alterations, representing a crucial target for therapy. With the introduction of Librovafz®, healthcare providers can offer patients a less invasive treatment option that caters to the increasing demand for convenience and efficacy in oncology care.

Dr. Hiroaki Akamatsu, an associate professor in the Respiratory and Tumor departments at Wakayama Medical University, remarked on the significance of this approval, stating, "The authorization of Librovafz® enhances the treatment experience for EGFR mutation-positive NSCLC patients and supports healthcare professionals in providing more efficient and effective care. With this innovative treatment, we hope to alleviate patient burdens and enhance their quality of life, allowing them to focus on what truly matters."

Chris Rieger, President of Johnson & Johnson Innovative Medicine Japan, noted, "The subcutaneous formulation of Librovafz® not only maintains the long-term survival benefits observed with the combination therapy of Livrebant® and Laziclus®, but it also improves treatment convenience and aims to substantially ease the burden on patients regarding their administration times."

A Pivotal Shift in NSCLC Management

With more than 80% of lung cancer cases deemed as NSCLC, the need for diverse and effective treatments continues to rise. Johnson & Johnson's commitment to innovative healthcare solutions underlines their ongoing research and funding into new therapies for cancer, immunology, neuropsychiatry, and cardiovascular diseases.

The approval of Librovafz® not only represents a triumph for lung cancer patients but also positions Johnson & Johnson at the forefront of medical innovation in Japan. As they prepare for upcoming application filings for extended dosing regimens through 2025, the future looks bright for patients needing effective and accessible cancer treatments.

This approval signals a broader movement towards incorporating patient-centric design into oncology therapeutics, reflecting the industry's commitment to enhancing patient outcomes and their treatment experiences. As Librovafz® becomes available, it allows for proactive care and broader access to vital treatments for NSCLC patients.

For continuous updates and further details, interested parties can visit Johnson & Johnson's Innovative Medicine Japan.