Neoplastic Process – Page 46

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

1 year ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

Innate Pharma Halts Phase 1b Trial for Peripheral T Cell Lymphoma Treatment Amidst NextCure Layoff Announcement

1 year ago talkbio0Tagged Innate Pharma, NextCure Layoffs, Peripheral T-Cell Lymphoma, Phase 1b Trial Termination

Innate Pharma, Peripheral T Cell Lymphoma, Phase 1b Trial Termination, NextCure Layoffs

Takeda’s $5.2B Ariad Deal Yields Label Expansion for Iclusig in Rare Leukemia

1 year ago talkbio0Tagged 5.2B, Ariad, expansion, Iclusig, Infrequent, Labels (device), leukemia, Takeda

Takeda, Ariad, $5.2B deal, Iclusig, Label expansion, Rare form of leukemia

Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks

1 year ago talkbio0Tagged Accelerated, Antibodies, Bispecific, Approved, BeiGene, Brukinsa, Chimeric Antigen Receptor T-cells, Clinical Trials, Combined Modality Therapy, competition, Disease Progression, Gazyva, Lymphoma, Follicular, obinutuzumab, ORR, Overall response rate, Rosewood, Toxicity aspects, United States Food and Drug Administration, zanubrutinib

Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies

FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment

1 year ago talkbio0Tagged cisplatin, Combined, Opdivo, Overall Survival

Overall Survival, Combined, cisplatin, Opdivo

BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma

1 year ago talkbio0Tagged Accelerated Approval, Approved, BeiGene, Brukinsa, Esophageal Neoplasms, Lymphoma, Follicular, obinutuzumab, tislelizumab, Trivimbra, United States Food and Drug Administration, zanubrutinib

BeiGene, Trivimbra (tislelizumab), Esophageal Cancer, Brukinsa (zanubrutinib), Follicular Lymphoma, FDA Approval, Accelerated Approval, Obinutuzumab

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

1 year ago talkbio0Tagged Accelerated, Approved, broadest label, Brukinsa, BTK Inhibitor, CHMP, Chronic lymphoma, Combined Modality Therapy, Lymphoma, Follicular, obinutuzumab, Oregon (geographic location), Overall response rate, Phase 2 Clinical Trials, Phase II ROSEWOOD trial, Recommendation, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Relapsing course, Rosewood, United States Food and Drug Administration

Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR

Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

1 year ago talkbio0Tagged amgen, Approved, Biosimilars, Cancer-related skeletal events, denosumab, interchangeable, Jubbonti, Osteoporosis, patent litigation, Prolia, sandoz, Secondary malignant neoplasm of bone, United States Food and Drug Administration, Wyost, Xgeva

Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation

NICE Rejects Coverage for AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Enhertu Due to Cost-Effectiveness Concerns

1 year ago talkbio0Tagged AstraZeneca, Cost Effectiveness, Coverage rejection, Daiichi Sankyo, Enhertu, Health Services, National, Malignant neoplasm of breast, Nitroglycerin/Sodium Citrate/Ethanol Solution, Technology

NICE, Enhertu, AstraZeneca, Daiichi Sankyo, Breast cancer, Cost-effectiveness, Coverage rejection, Technology Appraisal, National Health Service (NHS)

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

1 year ago talkbio0Tagged amivantamab-vmjw, Approved, carboplatin-pemetrexed chemotherapy, Disease Progression, EGFR Exon 20, first-line, Insertion Mutation, Johnson and Johnson, Mortality Risk, Non-Small Cell Lung Carcinoma, Objective Response Rate, ORR, Progression-Free Survival, Reduced, Rybrevant, United States Food and Drug Administration

Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)