USFDA Approves J&J’s Non-Small Cell Lung Cancer Drug
Lung Cancer Drugs Global Market Report 2021: COVID 19 Impact And Recovery To 2030 By The Business Research Company
The US Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug RYBREVANTTM is a bispecific antibody intended for patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The FDA simultaneously approved Guardant Health’s Guardant360® CDx liquid biopsy blood test as a companion diagnostic for use with RYBREVANTTM.[i] The lung cancer drugs market is growing rapidly according to the insights from the ‘Global Market Model’ of The Business Research Company.
The FDA has granted Breakthrough Therapy Designation (BTD) to this drug in March 2020 and initiated a Priority Review of the Biologics License Application (BLA) in December 2020. This is a first-in-class drug for NSCLC patients with exon 20 insertion mutations, and also the first lung cancer treatment approval for Johnson & Johnson.
Lung cancer is the leading cause of cancer death among both men and women, accounting for almost 25 % of all cancer deaths. NSCLC makes up 80 to 85% of all lung cancers. Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division. EGFR mutations are present in 10 to 15% of people with NSCLC adenocarcinoma and occur in 40 to 50% of Asians.
Currently, available targeted treatments like EGFR tyrosine kinase inhibitors (TKI) are not FDA approved and generally insensitive in treating NSCLC driven by EGFR exon 20 insertion mutations. In addition, NSCLC driven by this exon 20 mutation carries a worse prognosis and shorter survival rates compared with other common EGFR mutations, such as exon 19 deletions and L858R substitutions.
According to the Global Market Model of The Business Research Company, the global lung cancer drugs market is expected to grow from $8.06 billion in 2020 to $8.67 billion in 2021 at a compound annual growth rate (CAGR) of 7.6%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $12.84 billion in 2025 at a CAGR of 10.3%, and 19.1 billion by 2030. Targeted drug therapy in combination with other therapies is an emerging trend in the lung cancer market.
The global lung cancer drugs market report by TBRC is segmented as
1) By Disease Type: Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC)
2) By End User: Hospitals, Clinics, Others
3) By Drugs: Gemzar, Paraplatin, Taxotere, Navelbine, Avastin, Tarceva, Iressa, Others
The approval of RYBREVANTTM a fully human bispecific antibody directed against EGFR and MET receptors, highlights the growing market for bispecific antibodies, as published in the Global Bi-Specific MAbs Market Report by TBRC. According to the bi-specific MAbs global market report, the global bi-specific monoclonal antibody market is expected to grow from $2.93 billion in 2020 to $3.75 billion in 2021 at a compound annual growth rate (CAGR) of 28%. The market is expected to reach $10 billion in 2025 at a CAGR of 28%.
The Lung Cancer Drugs Global Market Report is one of a series of new reports from The Business Research Company that provides lung cancer drugs market overviews, analyzes and forecasts lung cancer drugs market size, share, lung cancer drugs market players, lung cancer drugs market segments and geographies, the market’s leading competitors’ revenues, profiles and market shares.
About The Author
Ravikiran has 12 years research experience in Biotechnology. He extensively worked with such companies/institutions as Ernst and Young (EY), DuPont and Center For Cellular & Molecular Biology (CCMB), Hyderabad. Ravikiran holds bachelor’s and master’s degrees in Biotechnology and Certification in Clinical Research from Institute of Clinical Research India (ICRI). In 2006, he took an advanced course in Bioinformatics at the Indian Institute of Chemicals Technology (IICT). Some of the clients he has worked for include Asahi Kasei Corporation, Fujifilm, and Sanofi Aventis. At TBRC, key projects he was involved in include a market study for bovine mastitis detection kits and research on multivalent pediatric vaccines.
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