-
FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
drugs
May 31, 2021
AMGN today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
-
CStone Announces the First-in-Class Registrational Clinical Trial of Sugemalimab Met its Primary Endpoint in Stage III NSCLC and Plans to Submit a New Drug Application
prnasia
May 28, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that a registrational clinical trial ...
-
FDA approves Janssen’s Rybrevant
pharmatimes
May 25, 2021
The US Food and Drug Administration (FDA) has approved Janssen’s Rybrevant as the first treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
-
U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer
prnasia
May 18, 2021
Innovent Biologics, Inc. and Eli Lilly and Company today jointly announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum ...
-
AstraZeneca’s Imfinzi and Tremelimumab with Chemotherapy Demonstrated Overall Survival Benefit in Trial for Non-Small Cell Lung Cancer
americanpharmaceuticalreview
May 08, 2021
The POSEIDON trial was a Phase III trial of AstraZeneca’s Imfinzi (durvalumab) plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) ...
-
Tecentriq approved for first-line metastatic NSCLC
pharmatimes
May 07, 2021
Roche’s checkpoint inhibitor Tecentriq has gained a new approval from the European Commission, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC), its fourth indication in this cancer type.
-
Alphamab announced PD-L1/CTLA-4 bispecific antibody KN046 will enter new Phase II clinical trial in combination with Pfizer's Inlyta® (axitinib)
prnasia
April 29, 2021
Alphamab Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer to evaluate the efficacy and safety of KN046 in combination with Inlyta® (axitinib) for the first-line treatment of NSCLC.
-
Tagrisso moves closer towards EU approval for early-stage lung cancer
pharmatimes
April 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s (AZ) Tagrisso for approval in the EU for the treatment of early-stage lung cancer patients.
-
NICE 'no' for Opdivo/Yervoy lung cancer combo
pharmatimes
April 13, 2021
The National Institute for Health and Care Excellence (NICE) has issued a preliminary no for NHS use of Bristol-Myers Squibb's Opdivo (nivolumab)/Yervoy (ipilimumab) combination for treating a certain lung cancer.
-
Bridge Biotherapeutics Announces Initiation of Phase 1/2 Clinical Trial of BBT-176 in EGFR-Mutant NSCLC with C797S
prnasia
April 07, 2021
Bridge Biotherapeutics Inc., a clinical-stage biotech company headquartered in Seongnam, Republic of Korea, announced that the company has initiated the Phase 1/2 clinical trial assessing safety, tolerability, and anti-tumor activity of BBT-176 in ...