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Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
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Opdivo® and Yervoy® combo increases mesothelioma survival
Opdivo and Yervoy displayed a 23 percent survival rate at three years compared to 15 percent with chemotherapy, Phase III trial shows.
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Neoadjuvant atezolizumab combination meets safety criteria in pleural mesothelioma
Neoadjuvant cisplatin and pemetrexed in combination with atezolizumab met safety criteria in resectable pleural mesothelioma clinical study.
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Erleada® reduces prostate-specific antigen (PSA) by 86 percent
Erleada achieved an 86 percent reduction in PSA at 12 months in the majority of patients, shows post-hoc analysis of Phase III study.
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Melflufen increases refractory multiple myeloma survival in Phase III study
Melfufen met the primary endpoint of superior progression free survival (PFS) with a median of 6.8 months in Phase III OCEAN trial.
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Imfinzi™ and tremelimumab combo improves NSCLC outcomes
Imfinizi™ and tremelimumab in combination with chemotherapy improved non-small lung cancer (NSCLC) survival by 23 percent in a Phase III study.
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Lumakras™ (sotorasib) helps control brain metastases
Amgen’s Lumakras™, a KRAS inhibitor, was found to improve the stability of brain metastases in a Phase II study.
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Phase III trials for asthma treatment meet all primary endpoints
Avillion reported positive results from MANDALA and DENALI Phase III trials of PT027, an albuterol/budesonide combination, in asthma patients.
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EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
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HIV vaccine fails to protect women against infection
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
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NICE approves inclisiran for LDL cholesterol reduction
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
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Increase in virtual trials improves patient accrual rates, finds report
The increased use of virtual components in clinical trials has led to fewer trial delays or terminations due to low participant numbers.
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Minjuvi® receives EC approval to treat large B-cell lymphoma
European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.
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FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
