Orphan drugs

China Ibrutinib Market Report 2021: By 2020, Pharmacyclics Inc is the Only Manufacturer in the Chinese Market - Forecast to 2025 - ResearchAndMarkets.com

Retrieved on:

Thursday, May 20, 2021

Health, Pharmaceutical, Chemical compounds, Countries, Organic compounds, Orphan drugs, Tyrosine kinase inhibitors, Breakthrough therapy, Acrylamides, Ibrutinib, Pyrazolopyrimidines, Economy of China, China

Their Ibrutinib, IMBRUVICA was launched in China in 2017.\nAccording to this market research, after Ibrutinib entered the Chinese market, the sales value of Ibrutinib in China has increased from CNY48,600 in 2017 to CNY 345.5 million in 2020.

Key Points:

Their Ibrutinib, IMBRUVICA was launched in China in 2017.\nAccording to this market research, after Ibrutinib entered the Chinese market, the sales value of Ibrutinib in China has increased from CNY48,600 in 2017 to CNY 345.5 million in 2020.
In 2020, the growth rate was 38.2%, which slowed down due to the COVID-19 epidemic.
On the other hand, China approves fewer indications for Ibrutinib than other countries do.
Therefore, the number of approved indications has the potential to increase, which means the market will keep expanding in the future.\n2 Sales of Ibrutinib in China, 2017-2020\n2.3 Sales of Ibrutinib by Dosage Form in China, 2017-2020\n3 Analysis of Major Ibrutinib Manufacturers in China, 2017-2020\n4 Prices of Ibrutinib for Different Manufacturers in China, 2020-2021\n5 Prospect of Chinese Ibrutinib drug Market, 2021-2025\n'

Forma Therapeutics to Present Data from Pivotal Phase 2 Trial of Olutasidenib at ASCO 2021

Retrieved on:

Thursday, May 20, 2021

The data indicate the duration of CR/CRh for people on treatment was 13.8 months.

Key Points:

The data indicate the duration of CR/CRh for people on treatment was 13.8 months.
\xe2\x80\x9cThe safety data from the treatment cohort are consistent with the findings from our Phase 1 evaluation in this high-risk AML patient population.
Phase 1 of the trial, 2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA).
The Phase 2 portion was an open-label, fixed-dose study of olutasidenib as a monotherapy and in combination with AZA in multiple IDH1m AML/MDS populations.

Eisai to Present Data on Oncology Pipeline and Products at ASCO Annual Meeting

Retrieved on:

Thursday, May 20, 2021

Chemical compounds, Cancer treatments, Drugs, Orphan drugs, Antineoplastic drugs, Eisai, Lenvatinib, Eribulin, Halichondrin B, Pembrolizumab, Merck & Co., Protein kinase inhibitor

b'TOKYO, May 20, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (2021 ASCO Annual Meeting*), to be held virtually from June 4 to 8, 2021.\nAt this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma.

Key Points:

b'TOKYO, May 20, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (2021 ASCO Annual Meeting*), to be held virtually from June 4 to 8, 2021.\nAt this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma.
Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.\nThis release discusses investigational compounds and investigational uses for FDA-approved products.
It is not intended to convey conclusions about efficacy and safety.
There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.\n'

Oncopeptides announces three abstracts accepted by the 2021 American Society of Clinical Oncology

Retrieved on:

Thursday, May 20, 2021

Drugs, Orphan drugs, Health sciences, Health, Daratumumab, Melphalan, LinkedIn

"This provides a clear rationale for our randomized phase 3 LIGHTHOUSE study, comparing subcutaneous daratumumab with or without melphalan flufenamide.

Key Points:

"This provides a clear rationale for our randomized phase 3 LIGHTHOUSE study, comparing subcutaneous daratumumab with or without melphalan flufenamide.
"\nBelow is a brief description of the abstracts that have been accepted by the ASCO.
Oncopeptides has one U.S. FDA approved product, PEPAXTO (melphalan flufenamide), known during clinical development as melflufen.
You may also visit our U.S. website at https://www.oncopeptides-us.com/en and follow us on our U.S. social media channels, Twitter and LinkedIn .\n'

Oncternal Therapeutics Presents Updated Interim Data for Cirmtuzumab in Combination with Ibrutinib at ASCO 2021

Retrieved on:

Wednesday, May 19, 2021

Drugs, Orphan drugs, Chemical compounds, Tyrosine kinase inhibitors, Organic compounds, Breakthrough therapy, Acrylamides, Ibrutinib, Piperidines, Chronic lymphocytic leukemia, WNT5A, ROR1

Adding cirmtuzumab to ibrutinib appears well tolerated, with no apparent additional toxicities noted to date,\xe2\x80\x9d said James Breitmeyer, M.D., Ph.D., Oncternal\xe2\x80\x99s President and CEO.

Key Points:

Adding cirmtuzumab to ibrutinib appears well tolerated, with no apparent additional toxicities noted to date,\xe2\x80\x9d said James Breitmeyer, M.D., Ph.D., Oncternal\xe2\x80\x99s President and CEO.
Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells.
The FDA has granted Orphan Drug Designations to cirmtuzumab for the treatment of MCL and CLL/small lymphocytic lymphoma.
This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.\n'

Sensei Biotherapeutics Announces New Clinical Data from the Ongoing Phase 1/2 Combination Trial of SNS-301 in Patients with Squamous Cell Carcinoma of the Head and Neck

Retrieved on:

Wednesday, May 19, 2021

Cancer treatments, Clinical medicine, Medicine, Cancer immunotherapy, Breakthrough therapy, Orphan drugs, Immune system, Antineoplastic drugs, Pembrolizumab, Squamous cell carcinoma, Head and neck cancer, Programmed cell death protein 1

The safety profile of SNS-301 in combination with pembrolizumab observed from 20 evaluable patients was favorable and consistent with previously reported data.

Key Points:

The safety profile of SNS-301 in combination with pembrolizumab observed from 20 evaluable patients was favorable and consistent with previously reported data.
Notably, the efficacy bar was set high by enrolling patients with no objective response to prior PD-1 blockade (median 7.5 months).
The company\xe2\x80\x99s most advanced immunotherapy, SNS-301, a first-in-class ImmunoPhage targeting the tumor antigen Aspartyl beta Hydroxylase (ASPH), is currently in a Phase 1/2 clinical trial in patients with advanced squamous cell carcinoma of the head and neck.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting

Retrieved on:

Wednesday, May 19, 2021

Health, Orphan drugs, Companies, CAC 40, Sanofi, Isatuximab, Oncology, Cancer, Breast cancer

b'Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer\nData that reinforce Libtayo\xc2\xae (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastases\nLonger term data and new analyses for Sarclisa\xc2\xae (isatuximab-irfc) further strengthen efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities\nPARIS \xe2\x80\x93 May 19, 2021 \xe2\x80\x93 New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8 highlights Sanofi\xe2\x80\x99s transformative science and commitment to patient care across difficult-to-treat cancers, including multiple myeloma, skin, lung and breast cancers.\n\xe2\x80\x9cOur pipeline of innovative investigational medicines continues to expand, supporting our goal to address critical gaps in treatment options for patients with cancers of high unmet need,\xe2\x80\x9d says Peter C. Adamson, Global Development Head, Oncology at Sanofi.

Key Points:

b'Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer\nData that reinforce Libtayo\xc2\xae (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastases\nLonger term data and new analyses for Sarclisa\xc2\xae (isatuximab-irfc) further strengthen efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities\nPARIS \xe2\x80\x93 May 19, 2021 \xe2\x80\x93 New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8 highlights Sanofi\xe2\x80\x99s transformative science and commitment to patient care across difficult-to-treat cancers, including multiple myeloma, skin, lung and breast cancers.\n\xe2\x80\x9cOur pipeline of innovative investigational medicines continues to expand, supporting our goal to address critical gaps in treatment options for patients with cancers of high unmet need,\xe2\x80\x9d says Peter C. Adamson, Global Development Head, Oncology at Sanofi.
We are a global biopharmaceutical company focused on human health.
We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.
We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.\nWith more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.\n'

Bicara Therapeutics to Present Clinical Data from Lead Immunotherapy Program, BCA101, at the American Society of Clinical Oncology 2021 Annual Meeting

Retrieved on:

Wednesday, May 19, 2021

Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation.

Key Points:

Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation.
A second arm of the study began enrolling patients for combination treatment with BCA101 and pembrolizumab, a PD-1 inhibitor, in January 2021.
Bicara\xe2\x80\x99s lead asset, BCA101, a first-in-class EGFR / TGF\xce\xb2-trap bifunctional antibody, is currently enrolling patients in a Phase 1/2 study.
Bicara\xe2\x80\x99s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210519005966/en/\n'

IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukaemia Demonstrates High Rates of Disease Control

Retrieved on:

Wednesday, May 19, 2021

Fixed-Duration (FD) First-Line Treatment (tx) with Ibrutinib (I) Plus Venetoclax (V) For Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Primary Analysis of the FD Cohort of the Phase 2 CAPTIVATE Study.

Key Points:

Fixed-Duration (FD) First-Line Treatment (tx) with Ibrutinib (I) Plus Venetoclax (V) For Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Primary Analysis of the FD Cohort of the Phase 2 CAPTIVATE Study.
Up to 7 Years of Follow-up in the RESONATE-2 Study of First-Line Ibrutinib Treatment for Patients With Chronic Lymphocytic Leukemia.
The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia.
Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

Data from Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 ASCO Annual Meeting

Retrieved on:

Wednesday, May 19, 2021

Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Antineoplastic drugs, Health care, Breakthrough therapy, Orphan drugs, American Society of Clinical Oncology, Incyte, Asco, Capmatinib, Non-small-cell lung carcinoma, Drugs, Health

b'Incyte (Nasdaq: INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually from June 4-8, 2021.\n\xe2\x80\x9cWe look forward to presenting data from across Incyte\xe2\x80\x99s oncology portfolio and partner programs at this year\xe2\x80\x99s ASCO Annual Meeting,\xe2\x80\x9d said Steven Stein, M.D., Chief Medical Officer, Incyte.

Key Points:

b'Incyte (Nasdaq: INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually from June 4-8, 2021.\n\xe2\x80\x9cWe look forward to presenting data from across Incyte\xe2\x80\x99s oncology portfolio and partner programs at this year\xe2\x80\x99s ASCO Annual Meeting,\xe2\x80\x9d said Steven Stein, M.D., Chief Medical Officer, Incyte.
)\nCapmatinib in MET Exon 14-Mutated, Advanced NSCLC: Updated Results from the GEOMETRY Mono-1 Study3(Abstract #9020.
)\nCapmatinib Efficacy in Patients with NSCLC Identified as METex14 Using an NGS-Based Liquid Biopsy Assay: Results from the GEOMETRY Mono-1 Study3(Abstract #9111.
)\nFor full session details and data presentation listings, please see the ASCO21 online program at https://meetinglibrary.asco.org .