2nd NSCLC Drug Development Summit
The 2nd NSCLC Drug Development Summit returns for its second year to unite biopharma and academic leaders during an exciting era of personalized medicine. The industry is uniting to address […]
NSCLC
Scotland is world’s first country to greenlight Tagrisso for NSCLC
Scotland has given the green light to AstraZeneca’s Tagrisso for restricted use to treat adult patients with non-small cell lung cancer (NSCLC), making it the […]
PharmaShots Interview: Dr. Trevor Feinstein and BeyondSpring Pharmaceuticals’ Dr. Lan Huang Shares Insight on the Data of Plinabulin + Docetaxel for NSCLC with EGFR Wild Type
In an interview with PharmaShots, Dr. Trevor Feinstein (Hematology Specialist in Fayetteville, GA) and Dr. Lan Huang (Co-founder, Chairman, and CEO at BeyondSpring) shared their views on the […]
Roche Entered into a Clinical Trial Supply Agreement with Galecto to Evaluate GB1211 + Tecentriq (atezolizumab) in P-IIa Trial for 1L Treatment of NSCLC
Shots: The companies collaborated to evaluate the safety, tumor shrinkage, clinical activity & immune biomarkers of Galecto’s GB1211 (galectin-3 inhibitor) + Roche’s Tecentriq (PD-L1 checkpoint […]
Roche scores early adjuvant lung cancer approval for Tecentriq
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage […]
Merck KGaA and GSK Terminate their ~$4.2B Collaboration Due to Clinical Failures
Shots: The companies terminated their collaboration that centered around bintrafusp alfa as the drug failed to show potential in INTR@PID Lung 037 study as the […]
ViewPoints Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC
In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Başkent University), Karl Lewis (Professor in the Division of […]
Innovent and AnHeart Report Interim Results of Taletrectinib (AB-106) in P-II TRUST Trial for the Treatment of ROS1-Positive NSCLC at CSCO 2021
Shots: The P-II TRUST trial evaluates taletrectinib (AB-106, ROS1/NTRK inhibitor) in 37 TKI-naïve or pre-treated patients with ROS1-positive NSCLC As of June 16, 2021 cut […]
ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda
There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer […]
Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC
Shots: The companies collaborated to evaluate the synergistic effects of BI 1701963 (SOS1::pan-KRAS inhibitor) + Lumakras (KRAS G12C inhibitor) in a P-I trial for adult […]
Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval
Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after […]
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC
Shots: The P-I CHRYSALIS study evaluates the safety, PK, and preliminary efficacy of Rybrevant (1050/1400 mg) as a monothx. and in combinations with lazertinib in […]
BeyondSpring Reports Results of Plinabulin + Docetaxel in P-III DUBLIN-3 Trial for 2L and 3L Treatment of NSCLC with EGFR Wild Type
Shots: The P-III DUBLIN-3 trial evaluates plinabulin + docetaxel vs docetaxel alone in 599 patients with 2L & 3L NSCLC EGFR wild type, with measurable […]
Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC
Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio […]
Merck’s targeted lung cancer drug tepotinib wins early access in UK
The UK drugs regulator has backed Merck KGaA’s MET inhibitor for the treatment of some patients with non-small cell lung cancer under the early access […]
Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan
Shots: The filing is based on the results from the P-III IMpower010 study assessing Tecentriq (1200mg, IV) vs BSC in 1,005 patients in a ratio […]
The US FDA Approves FoundationOne CDx for Alunbrig (brigatinib) in Patients with ALK+ NSCLC
Shots: The US FDA has approved FoundationOne CDx to be used as a CDx for Alunbrig (brigatinib) which is approved for the treatment of adult […]
Amgen nabs speedy approval for first-ever KRAS drug sotorasib
After decades of mostly unsuccessful R&D, Amgen has claimed the first ever regulatory approval for a drug that inhibits KRAS – a cancer target that […]
Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy
Shots: The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg, qd) in 124 patients with KRAS G12C […]
QIAGEN Collaborates with Mirati to Develop KRASG12C CDx for Non-Small Cell Lung Cancer
Shots: The companies collaborated to develop a tissue based KRAS Cdx test to identify patients with cancers that have a KRASG12C mutation who may benefit […]
Janssen claims FDA okay for would-be Tagrisso rival Rybrevant
Johnson & Johnson’s Janssen division has claimed a first approval in the US for its bispecific antibody Rybrevant as a treatment for EGFR-mutated non-small cell […]
Regeneron Receives CHMP’s Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC
Shots: The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no […]
Janssen’s Rybrevant (amivantamab-vmjw) Receives the US FDA’s Approval as the First Targeted Treatment for Patients with NSCLC with EGFR Exon 20 Insertion Mutations
Shots: The US FDA has granted accelerated approval which is based on P-I CHRYSALIS study assessing Rybrevant as a monothx. in patients metastatic non-small cell […]
BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program
Shots: Agenus to receive a $200M as up front & ~$1.36B as development, regulatory and commercial milestones plus royalties on net sales of the therapies. […]
Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who […]
Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC
Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. […]
ViewPoints Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC
In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of […]
Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation
Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The […]
EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, […]
Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer
Shots: The P-ll CodeBreaK 100 study involves assessing of Sotorasib (proposed INN for AMG 510, 960mg) in 126 patients with KRAS G12C-mutant advanced NSCLC, whose […]
AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer
Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage […]
Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC
Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people […]
