Antineoplastic drugs

Fidia announces the FDA Orphan Drug designation for ONCOFID®-P for the treatment of malignant mesothelioma, the cancer caused by exposure to asbestos

Retrieved on:

Monday, July 26, 2021

Cancer, Clinical medicine, Health, Infectious causes of cancer, Taxanes, Cancer treatments, Antineoplastic drugs, Mesothelioma, Paclitaxel, Bladder cancer, Chemotherapy

The loco-regional administration makes ONCOFID-P an ideal anticancer drug in combination with existing treatments for patients with malignant mesothelioma.

Key Points:

The loco-regional administration makes ONCOFID-P an ideal anticancer drug in combination with existing treatments for patients with malignant mesothelioma.
ONCOFID-P is an anticancer drug in advanced clinical development for the loco-regional treatment of non-muscle invasive bladder cancer, on which it has already demonstrated potent efficacy and excellent tolerability.
The onset of mesothelioma is closely related to exposure to asbestos, used as an insulator in many industries, from constructions to naval-aircraft and heavy industries.
ONCOFID-P is an innovative anti-cancer drug, a conjugate of paclitaxel (taxol) with hyaluronic acid (HA), resulting from the research of Fidia Farmaceutici.

Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Retrieved on:

Friday, July 23, 2021

Medicine, Health sciences, Cancer treatments, Antineoplastic drugs, Orphan drugs, Cancer immunotherapy, Breakthrough therapy, Pharmaceutical industry, Pembrolizumab, Eisai, Accelerated approval, Corticosteroid

Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.

Key Points:

Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.
Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to a pregnant woman.
Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.
"Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of KEYTRUDA plus LENVIMA in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."

LIXTE BIOTECHNOLOGY COMMENTS ON REPORT THAT ITS PP2A INHIBITOR LB-100 COMBINED WITH ANOTHER INVESTIGATIONAL AGENT STIMULATES BONE GROWTH IN MODELS OF DWARFISM

Retrieved on:

Thursday, July 22, 2021

Cancer, Clinical medicine, Medicine, Antineoplastic drugs, Cancer immunotherapy, Oncology, Immunotherapy, Chemotherapy

LB-100 has been shown to enhance anti-cancer activity of standard chemotherapy and immunotherapy regimens against a broad spectrum of human cancers in animal models.

Key Points:

LB-100 has been shown to enhance anti-cancer activity of standard chemotherapy and immunotherapy regimens against a broad spectrum of human cancers in animal models.
Our focus is to demonstrate the clinical therapeutic benefit of LB-100 in one or more cancers for which more effective treatments are urgently needed.
A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on and off.
This discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission at sec.gov/edgar.shtml .

FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Retrieved on:

Thursday, July 22, 2021

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points:

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
In KEYNOTE-775, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced endometrial carcinoma that were not MSI-H or dMMR (n=342), fatal adverse reactions occurred in 4.7% of patients.

Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML

Retrieved on:

Wednesday, July 21, 2021

Chemical compounds, Organic compounds, Heterocyclic compounds, Orphan drugs, Lactams, Nucleosides, Triazines, Antineoplastic drugs, Azacitidine, Venetoclax, H. Lee Moffitt Cancer Center & Research Institute, 7+3

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.

Key Points:

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.
The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting, said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute.
Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options.
A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission.

NOXXON Pharma Enters Second Clinical Collaboration With MSD to Evaluate NOX-A12 in Combination With KEYTRUDA® (Pembrolizumab) in Upcoming Phase 2 Pancreatic Cancer Study

Retrieved on:

Wednesday, July 21, 2021

This Phase 2 study will evaluate the safety and efficacy of NOX-A12, NOXXONs anti-CXCL12 agent, in combination with KEYTRUDA and two different chemotherapy regimens in patients with microsatellite stable pancreatic cancer.

Key Points:

This Phase 2 study will evaluate the safety and efficacy of NOX-A12, NOXXONs anti-CXCL12 agent, in combination with KEYTRUDA and two different chemotherapy regimens in patients with microsatellite stable pancreatic cancer.
The vast majority of pancreatic cancer patients have microsatellite stable tumors which are resistant to checkpoint inhibitor monotherapy.
MSD will provide pembrolizumab and expert advice for the study protocol, while NOXXON will sponsor the trial that will be conducted in clinical centers in the US and Europe.
NOX-A12 is currently developed in second-line pancreatic cancer in combination with Keytruda and in glioblastoma in combination with radiotherapy.

Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myelodysplastic Syndrome (MDS)

Retrieved on:

Wednesday, July 21, 2021

Chemical compounds, Branches of biology, Health, Antineoplastic drugs, Oncology, Syndromes, Tumor lysis syndrome, Venetoclax, Bcl-2, Cancer

NORTH CHICAGO, Ill., July 21, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA®) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) based on revised International Prognostic Scoring System (IPSS-R). A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.1 This marks the sixth BTD granted to venetoclax.

Key Points:

"This Breakthrough Therapy Designation underscores the need for more treatment options for these patients and the utility of venetoclax to potentially treat different forms of blood cancer."
Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers.
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS).TLS is caused by the fast breakdown of cancer cells.
Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

New Treatment Authorized and Available for Canadians with HER2+ Breast Cancer

Retrieved on:

Tuesday, July 20, 2021

Clinical medicine, Health, Drugs, Antineoplastic drugs, Breast cancer, Trastuzumab, Pertuzumab, Metastatic breast cancer, Cancer, Breast cancer management, Edith A. Perez

As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Key Points:

As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.
The Right Treatment for the Right Patient Personalised Treatment of Breast Cancer.
Subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of metastatic breast cancer in Canada - a budget impact analysis.
The Right Treatment for the Right Patient Personalised Treatment of Breast Cancer.

Bristol Myers Squibb Provides Update on CheckMate -651 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus EXTREME Regimen as First-Line Treatment for Squamous Cell Carcinoma of the Head and Neck

Retrieved on:

Friday, July 16, 2021

Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers.

Key Points:

Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Advaxis to Present at the Non-Small Cell Lung Cancer Drug Development Summit

Retrieved on:

Wednesday, July 14, 2021

Clinical medicine, Cancer treatments, Medicine, Cancer immunotherapy, Lung cancer, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Advaxis, Pembrolizumab, Merck & Co., Small-cell carcinoma

PRINCETON, N.J., July 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that Andres Gutierrez, M.D., Executive Vice President and Chief Medical Officer of Advaxis, will present data from Part B of the Companys Phase 1/2 study of ADXS-503 in combination with Pembrolizumab in patients with metastatic squamous or non-squamous non-small cell lung cancer at the virtual Non-Small Cell Lung Cancer Drug Development Summit on July 15th, 2021.

Key Points:

PRINCETON, N.J., July 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that Andres Gutierrez, M.D., Executive Vice President and Chief Medical Officer of Advaxis, will present data from Part B of the Companys Phase 1/2 study of ADXS-503 in combination with Pembrolizumab in patients with metastatic squamous or non-squamous non-small cell lung cancer at the virtual Non-Small Cell Lung Cancer Drug Development Summit on July 15th, 2021.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products.
These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,Kenilworth, N.J., USA.