Breakthrough therapy

CicloMed Announces Initiation of Phase 1B Trial of Fosciclopirox in Newly Diagnosed and Recurrent Urothelial Cancer Patients

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Tuesday, June 29, 2021

Cancer, Neoplasms, Carcinoma, Transitional cell carcinoma, Breakthrough therapy, Orphan drugs, Bladder cancer, Transitional epithelium, Pembrolizumab, Mark Soloway

We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.

Key Points:

We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.
We believe that fosciclopirox provides strong potential to improve treatment outcomes for patients with bladder cancer.
In September 2020, CicloMed was awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI), enabling the Phase 1B trial.
The initiation of this Phase 1B trial enables us to characterize the pharmacologic activity and mechanisms of fosciclopirox action following treatment in urothelial cancer patients, Weir added.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

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Tuesday, June 29, 2021

Bristol Myers Squibb (NYSE: BMY) announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.

Key Points:

Bristol Myers Squibb (NYSE: BMY) announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Iovance Biotherapeutics Announces Clinical Data for LN-145 in Non-Small Cell Lung Cancer

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Tuesday, June 29, 2021

Drugs, Lung cancer, Health sciences, Health, Breakthrough therapy, Orphan drugs, Non-small-cell lung carcinoma, Monoclonal antibodies, Treatment of lung cancer, Atezolizumab

The initial clinical results are available in a slide presentation on the Iovance website here .

Key Points:

The initial clinical results are available in a slide presentation on the Iovance website here .
Iovance anticipates presenting additional Cohort 3B data at a medical meeting in the second half of 2021.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, There remains a very significant unmet need to increase response rates and prolong survival in the second line non-small cell lung cancer treatment setting.
In addition, the companys TIL cell therapy is being investigated in a registration-supporting study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC).

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma

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Tuesday, June 29, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Cancer treatments, Medicine, Breakthrough therapy, Antineoplastic drugs, Orphan drugs, Cancer, Pembrolizumab, Trastuzumab, Microsatellite instability, HER2/neu, Esophageal cancer

Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide.

Key Points:

Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Vertex Announces National Reimbursement Agreement in France for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) and SYMKEVI® (tezacaftor/ivacaftor) for Eligible Cystic Fibrosis Patients

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Monday, June 28, 2021

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis (CF) medicines KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor.

Key Points:

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis (CF) medicines KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor.
Both medicines will be available for all eligible patients once the agreement has been published in the French Official Journal.
Through this national reimbursement agreement, eligible patients 12 years and older now have access to KAFTRIO and SYMKEVI.
The reimbursement agreement enables broad access to KAFTRIO for people with CF ages 12 years and older with one F508del mutation and one minimal function mutation.

Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma

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Monday, June 28, 2021

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause.

Key Points:

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause.
ZUMA-7 evaluated an one-time infusion of the CAR T-cell therapy Yescarta compared to SOC in adult patients with relapsed or refractory LBCL.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency

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Monday, June 28, 2021

Drugs, Orphan drugs, Fast track, Food and Drug Administration, Life sciences, Recombinant factor VIIa, Priority review, Health care, Breakthrough therapy, Drotrecogin alfa

A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.

Key Points:

A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.
Receiving a second Fast Track designation is another important milestone in our MarzAA development program.
FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, an SQ administered next-generation engineered rFVIIa for the episodic treatment of bleeding in subjects with rare bleeding disorders.

Vertex Announces New Portfolio Reimbursement Agreement in Italy Including KAFTRIO®, SYMKEVI® and Additional Indications of ORKAMBI® and KALYDECO® for Eligible Patients With Cystic Fibrosis

Retrieved on:

Friday, June 25, 2021

The agreement also expands access to KALYDECO (ivacaftor) for eligible patients ages one year and older.

Key Points:

The agreement also expands access to KALYDECO (ivacaftor) for eligible patients ages one year and older.
In addition, the agreement covers any new approved indication extensions for Vertexs CF medicines submitted and approved for reimbursement during the term of the contract.
Ludovic Fenaux, Senior Vice President, Vertex International, commented, This agreement is an important milestone for cystic fibrosis patients in Italy.
KALYDECO was first reimbursed in Italy in 2015, followed by ORKAMBI in 2017 for patients 12 years and older.

Bristol Myers Squibb Receives Positive CHMP Opinion for Anti-BCMA CAR T Cell Therapy Abecma (idecabtagene vicleucel) for Relapsed and Refractory Multiple Myeloma

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Friday, June 25, 2021

Research, Genetics, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Orphan drugs, Drugs, Health care, Branches of biology, Multiple myeloma, Protein domains, Breakthrough therapy, B-cell maturation antigen

As the first CAR T cell therapy for relapsed and refractory multiple myeloma to receive a positive CHMP opinion, Abecma represents a potential new treatment approach for patients in Europe battling this incurable blood cancer, said Noah Berkowitz, M.D., Ph.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.

Key Points:

As the first CAR T cell therapy for relapsed and refractory multiple myeloma to receive a positive CHMP opinion, Abecma represents a potential new treatment approach for patients in Europe battling this incurable blood cancer, said Noah Berkowitz, M.D., Ph.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.
The EMA previously granted Abecma access to the PRIority MEdicines (PRIME) scheme for the treatment of relapsed and refractory multiple myeloma.
Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

Retrieved on:

Friday, June 25, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Drugs, Medicine, Antineoplastic drugs, Orphan drugs, Breakthrough therapy, Bristol-Myers Squibb, Nivolumab, Chemoradiotherapy, Cabozantinib, Neoadjuvant therapy, Renal cell carcinoma

For many patients with localized esophageal or gastroesophageal junction cancer, the risk of recurrence is high, even after neoadjuvant chemoradiotherapy and surgery.

Key Points:

For many patients with localized esophageal or gastroesophageal junction cancer, the risk of recurrence is high, even after neoadjuvant chemoradiotherapy and surgery.
This leaves patients in need of additional treatment options, said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb.
Opdivo is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.
OPDIVO (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).