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Longer median overall survival in postmenopausal HR+ / HER2- metastatic breast cancer patients treated with Ribociclib

Updated median overall survival ( OS ) results for Ribociclib ( Kisqali ) in combination with Fulvestrant ( Faslodex ) in postmenopausal women with hormone receptor positive, human epidermal growth fa ... read article

Pirfenidone reduces scar tissue in patients with heart failure and preserved ejection fraction

Patients with heart failure with preserved ejection fraction who took the antifibrotic drug Pirfenidone ( Esbriet ) saw a significant reduction in a marker of heart muscle scarring compared with patie ... read article

Anti-LAG-3 antibody Relatlimab and Nivolumab in patients with previously untreated metastatic or unresectable melanoma: RELATIVITY-047 trial has met primary endpoint of progression-free survival

Primary results from the phase 2/3 RELATIVITY-047 trial evaluating the fixed-dose combination of Relatlimab, an anti-LAG-3 antibody, and Nivolumab ( Opdivo ) versus Nivolumab alone in patients with pr ... read article

Nivolumab plus chemotherapy and Nivolumab plus Ipilimumab have demonstrated superior survival benefit compared to chemotherapy in unresectable advanced or metastatic esophageal squamous cell carcinoma

Results from the phase 3 CheckMate -648 trial evaluating treatment with Nivolumab ( Opdivo ) plus chemotherapy or Nivolumab plus Ipilimumab ( Yervoy ) in patients with unresectable advanced or metasta ... read article

IMpower010: Atezolizumab improves disease-free survival in people with resectable early stage lung cancer compared to best supportive care

The phase III IMpower010 study evaluating Atezolizumab ( Tecentriq ), compared with best supportive care ( BSC ), has met its primary endpoint of disease-free survival ( DFS ) at the interim analysis. ... read article

EV-301 trial: survival advantage of Enfortumab vedotin in patients with previously treated advanced urothelial cancer

Results from the phase 3 EV-301 trial were presented at 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium ( ASCO GU ), and published in The New England Journal of Medicine ( N ... read article

Waldenström's macroglobulinemia: Imbruvica prescribing information updated to include long-term data

The U.S. Food and Drug Administration ( FDA ) has approved the update of the Imbruvica ( Ibrutinib ) Prescribing Information to include efficacy and safety data for the combination of Imbruvica with ... read article

CheckMate -816 trial: Nivolumab plus chemotherapy has shown statistically significant improvement in pathologic complete response as neoadjuvant treatment of resectable non-small cell lung cancer

The phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response ( pCR ) in resectable non-small cell lung cancer ( NSCLC ). In the trial, significantly more patients treated ... read article

IPATential150 study: Ipatasertib in combination with Abiraterone and Prednisone / Prednisolone met one of its co-primary endpoints in patients with metastatic castration-resistant prostate cancer and PTEN loss

The phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival ( rPFS ) in patients with metastatic castration-resistant prostate cancer ( mCRPC ) and whose tu ... read article

Opdivo plus Yervoy combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer, positive CHMP opinion

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended approval of Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles of Plat ... read article

FDA has granted accelerated approval to Zepzelca for metastatic small cell lung cancer

The FDA ( Food and Drug Administration ) has granted accelerated approval to Zepzelca ( Lurbinectedin ) for adult patients with metastatic small cell lung cancer ( SCLC ) with disease progression on o ... read article

CheckMate -577: Nivolumab as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer, has met primary endpoint of disease-free survival

The phase 3 CheckMate -577 trial evaluating Nivolumab ( Opdivo ) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction ( GEJ ) cancer met its primary endpoint of di ... read article

SELECTION trial: Filgotinib 200 mg has demonstrated greater efficacy compared with placebo in induction and maintenance of remission in patients with moderately to severely active ulcerative colitis

Results from SELECTION, a randomized, double-blind, placebo-controlled, phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor Filgotini ... read article

Venetoclax plus Azacitidine has demonstrated overall survival benefit and improved remission rates in treatment-naïve acute myeloid leukemia patients

The results from the VIALE-A trial, which has demonstrated that previously-untreated patients with acute myeloid leukemia ( AML ) who were ineligible for intensive chemotherapy treated with Venetoclax ... read article

Osimertinib: ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer

The ADAURA phase III trial for Osimertinib ( Tagrisso ) in the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated ( EGFRm ) non-small cell lung cancer ( ... read article

Focus

Multiple sclerosis: FDA has approved Tecfidera

The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ... read article

Apremilast linked to significant and clinically meaningful improvements for the primary and major secondary endpoint in plaque psoriasis

Celgene has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving Apremilast 30 mg BID monotherapy in both the ESTEEM 1 and 2 phase ... read article

Kadcyla, a new treatment for late-stage breast cancer, approved by Food and Drug Administration

The U.S. Food and Drug Administration ) has approved Kadcyla ( Ado-Trastuzumab Emtansine ), a new therapy for patients with HER2-positive, late-stage ( metastatic ) breast cancer.HER2 is a protein inv ... read article

FISSION and NEUTRINO trial: Sofosbuvir has met primary endpoints for hepatitis C

Results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide Sofosbuvir in combination with Ribavirin ( FISSION ) and in combination with Ribavirin ... read article

Increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA less than or equal to 3.0 ng/mL at baseline taking Finasteride 5 mg/day ( 5 times the dose of Propecia ) in the 7-year Prostate Ca ... read article

Castration-resistant prostate cancer: Cabozantinib linked to high rates of complete or partial bone scan resolution, pain relief, improvements in hemoglobin, and tumor regression

Exelixis has reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer ( CRPC ) treated with Cabozantinib ( XL184; Cometriq ) in an ongoing phase 2 ... read article