Adjuvant

AZ, Merck get EU nod for Lynparza as adjuvant breast cancer therapy

The European Commission has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over would-be rivals in the PARP inhibitor class. The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before …

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BMS’ plan to move Opdivo into adjuvant RCC gets knocked back

Bristol-Myers Squibb has revealed that its checkpoint inhibitor combination of Opdivo and Yervoy failed a phase 3 trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most common form of kidney cancer. The disappointing outcome from the CheckMate -914 trial undermines BMS’ hopes of moving PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy …

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Roche’s Tecentriq extends lead over Keytruda in adjuvant NSCLC

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 Tecentriq – treatment of early-stage cases that are treatable with surgery. Roche claimed FDA approval for Tecentriq (atezolizumab) in the US last year as an adjuvant for some NSCLC patients, …

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Merck fights back against Roche in adjuvant lung cancer therapy

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 used to prevent the cancer returning after surgery to remove it in a phase 3 trial. The results of the KEYNOTE-091 trial showed that Keytruda (pembrolizumab) reduced death or disease …

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GSK gets £1.4bn sales lift from COVID-19 products in 2021

GlaxoSmithKline’s COVID-19 products – antibody drug Xevudy and a vaccine adjuvant – helped drive a 5% increase in 2021 revenues to £34 billion ($46 billion), ahead of what chief executive Emma Walmsley says will be a “landmark year” for the company. Xevudy (sotrovimab), which was developed with Vir Biotech and has seen its use rise …

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Merck gets EU nod for Keytruda in adjuvant kidney cancer

Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European Commission approving use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). Adjuvant treatment moves use of the drug into patients with earlier-stage cancer, a key strategy …

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Chasing Roche, Merck unveils adjuvant lung cancer data for Keytruda

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 early-stage, adjuvant treatment setting. Now, it’s hoping to fight back with new phase 3 data. In the KEYNOTE-091 trial, Keytruda (pembrolizumab) significantly improved disease-free survival compared to placebo when given …

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NICE gives Keytruda parity with Opdivo for adjuvant melanoma

After three years of availability via the Cancer Drugs Fund (CDF), MSD’s checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery for people with melanoma to prevent the cancer returning. PD-1 inhibitor Keytruda (pembrolizumab) has been recommended by NICE for adjuvant treatment of adults with stage 3 melanoma that has spread …

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Merck claims another adjuvant okay from FDA for Keytruda

Merck & Co’s strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for adjuvant treatment of skin cancer melanoma. The US regulator has approved Keytruda (pembrolizumab) as a treatment for melanoma patents aged 12 and over with stage 2B, 2C and 3 tumours …

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AZ eyes FDA verdict on Lynparza in adjuvant breast cancer in Q1

The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already …

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Merck wins FDA nod for Keytruda as adjuvant kidney cancer treatment

Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA greenlit use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). The checkpoint inhibitor has been approved for use after surgery in patients with RCC – the …

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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 cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or …

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BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who …

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FDA starts speedy review of Keytruda for adjuvant kidney cancer

Merck & Co is looking at a decision from the FDA in December on its application to market Keytruda as a post-surgery treatment for people with kidney cancer, after a priority review. The drugmaker – known as MSD outside the US and Canada – is seeking approval of Keytruda (pembrolizumab) as an adjuvant treatment for …

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Roche gets fast FDA review for Tecentriq in adjuvant lung cancer

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 with non-small cell lung cancer (NSCLC). The US regulator has just started a priority review of the marketing application for Tecentriq (atezolizumab) – given after surgery and platinum-based chemotherapy – …

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BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy

Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position with an EU approval in the post-surgery (adjuvant) setting. The European Commission has approved Opdivo (nivolumab) as the first-ever adjuvant immunotherapy for patients with oesophageal or gastroesophageal junction (GEJ) cancer, …

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ASCO21: Lynparza aces adjuvant breast cancer therapy trial

AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to …

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AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results: Improvement in DFS in all population, 83% reduction in the …

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer Read More »

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs i.e DFS while the trial will continue to evaluate its …

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma Read More »

Filing beckons as Lynparza hits the mark in adjuvant breast cancer

AstraZeneca’s PARP inhibitor Lynparza has shown a clinical benefit when given as an adjuvant for early breast cancer, according to the data monitoring body for the phase 3 OlympiA trial.  At an interim analysis, Lynparza (olaparib) reduced recurrence of disease compared to placebo in women with BRCA-mutated, HER2-negative breast cancer after surgery and chemotherapy to …

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AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots: AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or …

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer Read More »