Merck Archives | PharmaShots

AstraZeneca and Merck’s Lynparza (olaparib) Receive CHMP’s Positive Opinion for 1L Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer

April 29, 2019April 30, 2019Shiwani Sharma

Shots: The positive opinion is based on SOLO-1 P-III study results assessing Lynparza (300mg, bid) as a monothx vs PBO in 391 patients [...]

Merck Reports Updated Results of Keytruda (pembrolizumab) in P-III KEYNOTE-062 Study as a Monotherapy for 1L Treatment of Advanced Gastric Cancer

April 26, 2019April 30, 2019Tuba Khan

Shots: The P-III KEYNOTE-062 (NCT02494583) study involves assessing of Keytruda as monothx. and in combination with CT (cisplatin/5-fluorouracil/capecitabine) & CT as monthx. in [...]

Merck’s Keytruda (pembrolizumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

April 22, 2019April 24, 2019Tuba Khan

Shots: The approval is based on P-III KEYNOTE-426 study assessing Keytruda (pembrolizumab, 200mg, q3w up to 24mos.) + Inlyta (axitinib,5mg, bid) vs sunitinib [...]

Tessa Collaborates with Merck to Evaluate a Combination Therapy for Metastatic or Recurrent Cervical Cancer

April 17, 2019April 24, 2019Shiwani Sharma

Shots: Tessa to conduct a P-Ib/II trial assessing Tessa’s human papillomavirus-specific T cell (HPVST) therapy or TT12 with Merck’s Keytruda (pembrolizumab) for patients [...]

Merck’s Keytruda (pembrolizumab) Receives FDA’s Expanded Monotherapy Label Approval for Patients with 1L Stage III Non-Small Cell Lung Cancer (NSCLC)

April 12, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III KEYNOTE-042 trial results assessing Keytruda (200mg, q3w) vs CT in 1274 patients in ratio (1:1) with [...]

AstraZeneca and Merck’s Lynparza (olaparib) Receive EU’s Approval as a Monotherapy to Treat Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

April 10, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III OlympiAD trial assessing Lynparza (300mg, bid) vs CT (capecitabine, eribulin or vinorelbine) in 302 patients with [...]

Myriad Expands its Companion Diagnostic Collaboration with AstraZeneca and Merck

April 5, 2019April 24, 2019Tuba Khan

Shots: AstraZeneca & Merck will utilize Myriads’ BRAC Analysis CDx to identify germline BRCA mutations in men who have mCRPC cancer, enrolled in [...]

Merck’s Keytruda (pembrolizumab) + Chemotherapy Receive NMPA’s (CFDA) Approval for 1L Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

April 2, 2019April 4, 2019Shiwani Sharma

Shots: The approval is based on P-III KEYNOTE-189 trial assessing Keytruda + pemetrexed & Pt CT in patients with 1L metastatic non-sq NSCLC, [...]

Merck Extends its Strategic Collaboration with NGM Biopharmaceuticals

March 22, 2019April 24, 2019Tuba Khan

Shots: Merck exercises its option to extend its Feb,2015 agreement with NGM for development and commercialization of novel biologics therapies. NGM to receive [...]

Merck’s Keytruda + Chemotherapy Receive EU’s Approval for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

March 14, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III KEYNOTE-407 study assessing Keytruda + carboplatin/nab paclitaxel vs carboplatin/nab paclitaxel monothx. in ratio (1:1) in patients [...]