Tagrisso paired with Hutchmed drug clears lung cancer test
EGFR inhibitors like AstraZeneca’s Tagrisso have been hugely successful in treating EGFR-positive lung cancer, but the durability of treatment is often reduced by resistance mutations. […]
EGFR inhibitors like AstraZeneca’s Tagrisso have been hugely successful in treating EGFR-positive lung cancer, but the durability of treatment is often reduced by resistance mutations. […]
Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to […]
While Merck & Co’s Keytruda is the undisputed leader of the non-small cell lung cancer (NSCLC) category, there’s one category where it lags behind Roche’s […]
Mirati Therapeutics will hear from the FDA on its KRAS inhibitor adagrasib later this year, hoping to compete with first-to-market rival Lumakras from Amgen. However, […]
Roche’s anti-TIGIT antibody tiragolumab has failed a second phase 3 trial, dousing expectations for the programme and its hopes of finding a companion to its […]
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – […]
AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu […]
Novartis has joined the select cadre of drugmakers developing KRAS inhibitors for cancer, opening its account with phase 1b data on JDQ443 showing efficacy in […]
The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of […]
Researchers at the Institute of Cancer Research (ICR) in London have designed a prototype test that they think could be used to predict which combinations […]
Merck & Co’s Keytruda is poised to move even earlier in the treatment of patients with non-small cell lung cancer (NSCLC) after showing efficacy when […]
Bristol-Myers Squibb’s Opdivo has been playing second fiddle to Merck & Co’s Keytruda in the non-small cell lung cancer (NSCLC) market for years, but now […]
Coverage for lung cancer screening has been expanding in the private market, even before a […]
FDA advisors have voted against approval of Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab, undermining hopes of a new, lower-priced option in the PD-1/PD-L1 […]
The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place […]
Merck & Co’s Keytruda is the undisputed market leader in immunotherapy for non-small cell lung cancer (NSCLC), but was leapfrogged by Roche’s Tecentriq in the […]
Amgen now has regulatory approval on both sides of the Atlantic for Lumykras, the culmination of many years of effort to bring a drug to […]
The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug […]
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The […]
Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. […]
Roche’s closely-watched combination of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq has shown long-term efficacy in an ongoing trial in lung cancer, adding to the […]
Targeted cancer drug specialist Blueprint Medicines has agreed to pay $250 million upfront to acquire Lengo Therapeutics and its lead drug for lung cancer, a […]
Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorization for Lumykras to treat advanced NSCLC with KRAS G12C mutation & […]
The dominance of Merck & Co’s Keytruda in the treatment of previously-untreated non-small cell lung cancer (NSCLC) means it will be hard to dislodge – […]
Shots: The P-III ORIENT-31 study evaluates sintilimab with/out Byvasda + CT vs CT in a ratio (1:1:1) in patients with EGFR-mutated LA or metastatic nonsq. […]
Shots: The approval is based on P-III IMpower010 study Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical […]
A research project between Bayer and digital health company Huma will use artificial intelligence to detect lung cancer in CT scans – and determine which […]
Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS […]
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With […]
Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C […]
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver […]
Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone […]
Shots: The companies initiate P-III SANOVO study to evaluates the efficacy & safety of Orpathys in combination with AstraZeneca’s Tagrisso (irreversible EGFR TKI) vs Tagrisso […]
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The […]
Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for […]
Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients […]
The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the […]
Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent […]
FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS […]
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 […]
Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. […]
Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment […]
Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a […]
Shots: The P-II trial will evaluate the efficacy, safety, and tolerability of KN046 + Pfizer’s Inlyta (axitinib) as a 1L treatment of NSCLC. The 1EPs […]
Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, […]
Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with […]
Shots: The P-III IMpower010 study involves assessing Tecentriq vs BSC, in 1,005 participants in a ratio (1:1) with stage IB-IIIA NSCLC, following surgical resection and […]
Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. […]
The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer […]
Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. […]
Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Like PD-L1, TIGIT […]
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to […]
An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective […]
The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they […]
The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. Results from the phase 3 ADAURA […]
The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the […]
Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator […]
Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some […]
Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA […]
Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles […]
Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC […]
Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC […]
Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent […]
Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ […]
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