Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study. The survival benefits were seen in patients regardless of PD-L1 status. The…
FDA approves new Opdivo indications for upper gastroesophageal cancers
Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC. Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.…
Janssen EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients
Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Rybrevant is a fully-human EGFR-MET bispecific antibody. NSCL is responsible for the majority of lung cancers. The Conditional Marketing Authorisation (CMA) covers patients who have failed…
AstraZeneca’s Imfinzi and tremelimumab show promise in non-small cell lung cancer study
AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON. Imfinzi and tremelimumab are immune checkpoint…
Roche withdraws approval application for Tecentriq in mTNBC
Roche (OTCQX:RHHBY) has voluntarily withdrawn its application for FDA accelerated approval for the monoclonal antibody Tecentriq (atezolizumab) in combination with chemotherapy to treat unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) with tumors expressing programmed death-ligand 1 (PD-L1). Earlier this month, Roche won priority review for Tecentriq for people with non-small cell lung cancer…
Asparlas effective against acute lymphoblastic leukemia
Asparlas from Servier Pharmaceuticals is an asparagine-specific enzyme that is FDA-indicated as a treatment for acute lymphoblastic leukemia in patients aged one month to 21 years. In 2018, FDA approved the drug for use as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL).