Vepdegestrant (ARV-471) monotherapy has been granted fast track designation by the FDA as a treatment for adult patients with estrogen receptor (ER)–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior treatment with endocrine-based therapy. This designation was granted in February 2024. Vepdegestrant was found to have ER degradation rates of up to 97% in tumor cells, as indicated by preclinical studies. Furthermore, the agent exhibited enhanced anti-tumor activity in comparison to fulvestrant (Faslodex) when administered as monotherapy or in combination with a CDK4/6 inhibitor, as well as tumor shrinkage in ER-driven xenograft models. They are committed to addressing the persistent unmet requirements of individuals with ER-positive, HER2-negative breast cancer and are making every effort to accelerate the development of vepdegestrant as a novel, oral ER-targeted potential therapy for this patient population. They are delighted that the FDA has granted fast track designation for vepdegestrant, and we remain convinced that this investigational medication has the potential to utilize the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.
In October 2023, the FDA approved Entrectinib (Rozlytrek) as a treatment for pediatric patients with solid tumors that contain an NTRK gene fusion. In order to qualify, patients must be at least one month of age, have metastatic disease, have no known acquired resistance mutation, and have no standard or satisfactory standard therapy options. Additionally, a novel oral pellet formulation was authorized by the regulatory agency. The decision was substantiated by the results of 33 pediatric patients who were enrolled in one of two multicenter, single-arm clinical trials: the phase 1/2 STARTRK-NG trial (NCT02650401) or the phase 2 TAPISTRY trial (NCT04589845). Patients were administered entrectinib orally or through an enteral feeding tube in 4-week cycles, with once-daily doses ranging from 20 mg to 600 mg, based on their body surface area. The open-label, multicenter trials included pediatric patients with unresectable or metastatic solid tumors that contained an NTRK gene fusion. The patients had measurable or evaluable disease at baseline and had not previously been exposed to a TRK inhibitor. In order to be included in the analysis, participants were required to have received a minimum of one dose of entrectinib and have a minimum of six months of follow-up.
Segmentation
The spindle cell sarcoma treatment market has been segmented on the basis of types of treatment and end-user.
On the basis of types of treatment, the spindle cell sarcoma treatment market is segmented into surgical removal, cryotherapy, radiotherapy, hormone therapy, and Chemotherapy. Surgical therapy is further sub-segmented into conservative surgical removal type and wide surgical removal type.
On the basis of end-user, the spindle cell sarcoma treatment market is segmented into hospital, clinics, and others.
Key players
Key players for the spindle cell sarcoma treatment market are PharmaEngine, Inc, Morphotek Inc, Threshold Pharmaceutical, Merck KGaA, NantCell Inc, NanoCarrier Co., Ltd, Athenex, Inc.
Regional Market Summary
On a regional basis, the market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa.
Americas is likely to dominate the spindle cell sarcoma treatment market owing to the remarkable use of chemotherapy for the prevention of disease and favorable conditions for research and development.
According to a scientific report, of Surveillance, Epidemiology and End Results (SEER) database white people account for 79.1 % with spindle cell sarcoma cancer within the median age of 57 years.
Europe is the second largest market for the spindle cell sarcoma treatment followed by Asia-Pacific. Due to the availability of fund for research and development activity and growing emphasis on treating disease. Asia-Pacific shows the fastest growth in the market due to an increase in the prevalence of communicable disease. India and China are expected to be the fastest growing market for spindle cell sarcoma treatment.
The Middle East and Africa has the lowest market for spindle cell sarcoma treatment due to poor medical facilities and lack of technology.
Spindle Cell Sarcoma Treatment Market, by Types of Treatment
- Radiotherapy
- Chemotherapy
- Hormone Therapy
- Surgical Removal
- Conservative Surgical Removal Type
- Wide Surgical Removal Type
- Cryotherapy
Spindle Cell Sarcoma Treatment Market, by End-User
- Laboratories
- Hospitals
- Clinics
- Others
Spindle Cell Sarcoma Treatment Market, by Region
- Americas
- North America
- US
- Canada
- South America
- Europe
- Western Europe
- Germany
- France
- Italy
- Spain
- UK
- Rest of Western Europe
- Eastern Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- Republic of Korea
- Rest of Asia-Pacific
- Middle East & Africa
Spindle Cell Sarcoma Treatment Market, by Key Players
- PharmaEngine, Inc
- Morphotek Inc
- Threshold Pharmaceutical
- Merck KGaA
- NantCell Inc
- NanoCarrier Co., Ltd
- Athenex, Inc.
Recent Developmet
PharmaEngine, Inc. is a company in the market for sarcoma medications that are highly consolidated. In terms of market share, all of the companies are currently dominant including this. Mid-size to smaller enterprises are projected to infiltrate the market by introducing new pharmaceuticals at lower prices, thanks to technology developments and product innovations. As a result, these newcomers are expected to have a significant future share including Morphotek Inc.
Intended Audience
- Hospitals and clinics
- Laboratories and associations