Entries by clickgiant

Keytruda Monotherapy Approved for 1L PD-L1-Positive NSCLC in China

October 11, 2019 Impact: High Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic NSCLC tumors with PD-L1 expression of at least 1% (TPS ≥1%, determined by an NMPA-approved test), without EGFR or ALK […]

Keytruda/Lenvima Combination Receives Accelerated Approval for 2L+ Endometrial Carcinoma

October 1, 2019 Impact: High Merck and Eisai have announced that FDA has granted an accelerated approval to the combination treatment of Keytruda/Lenvima (pembrolizumab/lenvatinib) for patients with advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient), who have disease progression following prior systemic therapy and are not candidates for curative […]

FDA Approves Ardelyx Tenapanor (Ibsrela) for IBS-C

September 25, 2019 Impact: High Ardelyx received FDA approval for tenapanor for the treatment of IBS-C in adults. The approval was based on two phase 3 clinical trials, T3MPO 1 and T3MPO2. The brand name for the drug will be Ibsrela. The label contains a black box warning on the risk of serious dehydration in […]

Pivotal DREAMM-2 Study of GSK’s Belantamab Mafodotin is Positive

September 4, 2019 Impact: High GSK has announced that the pivotal phase 2 DREAMM-2 trial (NCT03525678) of belantamab mafodotin has met the primary endpoint of ORR. 196 relapsed multiple myeloma patients who were refractory to an immunomodulatory drug, a PI and an anti-CD38 antibody were enrolled. Safety and tolerability are reportedly consistent with what was observed […]

Amgen Wins U.S. Patent Case on Enbrel

August 21, 2019 Impact: High Amgen announced that the U.S. District court of New Jersey ruled in favor of Amgen regarding the validity of two patents protecting exclusivity of Enbrel from biosimilars.  Sandoz immediately announced that it would appeal the ruling.

Keytruda Monotherapy Approved for 2L+ Esophageal Cancer

August 13, 2019 Impact: High Get insight from inThought Research experts on the recent approval of Keytruda Monotherapy for 2L+ Esophageal cancer: Merck has announced that FDA has approved Keytruda (pembrolizumab) as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score […]

Novartis’ PARAGON-HF Trial Evaluating Entresto in HFpEF Misses Primary Endpoint

July 25, 2019 Impact: High Get insight from inThought Research experts on Novartis results from the phase 3 PARAGON-HF clinical trial evaluating Entresto versus valsartan in HFpEF. Novartis announced topline results from the phase 3 PARAGON-HF study evaluating Entresto versus valsartan in HFpEF. The primary endpoint of reducing cardiovascular death and total heart failure hospitalizations […]

Phase 3 CheckMate – 227 update in 1L NSCLC: survival benefit with Opdivo/Yervoy but not Opdivo/chemotherapy

July 25, 2019 Impact: High Bristol-Myers Squibb has provided updates on Part 1a and Part 2 of the Phase 3 CheckMate -227 study of Opdivo in 1L NSCLC. Part 1a, which evaluated Opdivo and Yervoy vs. chemotherapy, met the co-primary endpoint of overall survival in patients with tumor expression levels of PD-L1 > 1%. A survival benefit […]

FDA Approves Gene Therapy for Spinal Muscular Atrophy

July 23, 2019 Impact: High Zolgensma is approved for the treatment of pediatric patients less than 2 years of age with SMA including those who are pre-symptomatic at diagnosis. Zolgensma is designed to address the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression with a single, […]