Mutation – Talk Bio

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

2 weeks ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

3 months ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

AstraZeneca Details Its Oral SERD ‘Switching’ Regimen Amid Feasibility Questions

3 months ago talkbio0Tagged AstraZeneca, camizestrant, CDK4/6 inhibitor, Disease Progression, ESR1 gene, Malignant neoplasm of breast, Mutation, Oral SERD, SERENA-6 trial, treatment resistance

AstraZeneca; oral SERD; camizestrant; breast cancer; ESR1 mutation; SERENA-6 trial; CDK4/6 inhibitor; disease progression; ASCO 2025; treatment resistance

Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program

7 months ago talkbio0Tagged AML, Breakthrough Therapy, DNA Sequence Rearrangement, Identifier, KMT2A gene, KOMET-001, KOMET-017, Leukemia, Myelocytic, Acute, Menin Inhibitor, Mutation, NPM1, NPM1 gene, Phase 3 trials, Ziftomenib

Ziftomenib, Acute Myeloid Leukemia (AML), NPM1 mutation, KMT2A rearrangement, Phase 3 trials, KOMET-001, KOMET-017, Menin inhibitor, Breakthrough Therapy Designation

J&J’s Subcutaneous Rybrevant Receives CHMP Backing for Lung Cancer Treatment Despite Recent FDA Rejection

7 months ago talkbio0Tagged amivantamab, CHMP, Epidermal Growth Factor Receptor, Johnson & Johnson, Mutation, Non-Small Cell Lung Carcinoma, Rybrevant, subcutaneous formulation, United States Food and Drug Administration

Rybrevant, amivantamab, Johnson & Johnson, CHMP, FDA, subcutaneous formulation, non-small cell lung cancer, EGFR mutations

J&J’s Rybrevant-Lazcluze Combo Demonstrates Superior Survival Benefit Over Tagrisso in EGFR-Mutated NSCLC

7 months ago talkbio0Tagged chemotherapy-free regimen, Epidermal Growth Factor Receptor, Lazcluze, Mutation, Non-Small Cell Lung Carcinoma, Overall Survival, Phase III MARIPOSA trial, Rybrevant, Tagrisso

Rybrevant, Lazcluze, Tagrisso, NSCLC, EGFR mutation, overall survival, Phase III MARIPOSA trial, chemotherapy-free regimen

AstraZeneca’s Tagrisso Expands EU Approval for NSCLC Treatment

8 months ago talkbio0Tagged Approved, AstraZeneca, Epidermal Growth Factor Receptor, EU, Malignant neoplasm of lung, Mutation, Non-Small Cell Lung Carcinoma, Tagrisso

AstraZeneca, Tagrisso, NSCLC, EU approval, EGFR mutations, lung cancer treatment

FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns

8 months ago talkbio0Tagged Epidermal Growth Factor Receptor, J&J, Malignant neoplasm of lung, manufacturing issues, Mutation, Non-Small Cell Lung Carcinoma, Rejection, Subcutaneous Rybrevant, United States Food and Drug Administration

FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations