May 05, 2022
Jakavi was approved for steroid-refractory graft-versus-host disease by European Commission.
Novartis announced that the European Commission approved Jakavi (ruxolitinib) for 12 years and older patients with steroid-refractory graft-versus-host disease (GvHD). Novartis announced that Jakavi would be the first JAK1/2 inhibitor approved for GvHD. GvHD occurs in 50% of patients who had allogenic stem cell transplants.
The approval was based on two Phase 3 clinical trials - Phase III REACH2 and REACH3 trials. Jakavi showed significant improvement in the overall response rate (ORR) compared to the best available therapy. In the REACH2 trial, ORR was 62% ORR in Jakavi on day 28, compared to 39% in patients on the best available therapy. At week 24, in the REACH3 trial, ORR was 50% vs. 26% in patients on best available therapy, 76% vs. 60% in patients who have steroid-refractory/dependent chronic GvHD.
GvHD occurs when the donor cells consider recipient cells as foreign cells and attack them. Jakavi is a JAK 1 and JAK 2 tyrosine kinases inhibitor licensed for commercialization from Incyte by Novartis outside the US.
May 04, 2022
Kymriah received European Commission approval for follicular lymphoma
The European Commission approved Kymriah for adult patients with relapsed or refractory follicular lymphoma. Novartis announced that Kymriah is the first CAR-T cell therapy approved for relapsed or refractory follicular lymphoma (grades 1, 2, and 3A) in Europe.
The approval was based on the Phase II ELARA trial, in which Kymriah demonstrated a high response rate. 86% of patients treated with Kymriah showed the response, and 69% of patients had a complete response.
Cytokine release syndrome (CRS) syndrome was reported in 50% of patients, and neurological adverse events in 9% of patients.
Previously Kymriah was approved for young adult patients with B cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post‑transplant or in second or later relapse, and adult patients with r/r diffuse large B cell lymphoma (DLBCL) who were previously treated with two or more systemic therapies.
April 13, 2022
European Commission approved Padcev for urothelial cancer
Seagen and Astellas announced that the European Commission approved Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer. It is approved for patients who were previously treated with platinum-containing chemotherapy and a PD-1/L1 inhibitor.
The approval is based on the phase 3 EV-301 trial, in which Padcev demonstrated significant improvement in the overall survival compared to chemotherapy. In the trial, 608 patients were enrolled. At the time of interim analysis, median overall survival was 12.9 months in Padcev arm versus 9 months in patients on chemotherapy.
April 04, 2022
Bristol Myers Squibb's Breyanzi is approved for relapsed or refractory large B-cell lymphoma in Europe
Bristol Myers Squibb announced that Breyanzi (lisocabtagene maraleucel) received market authorization from the European Union for treating certain forms of relapsed or refractory large B-cell lymphoma.
The approval is based on the TRANSCEND NHL 001 trial, which included 216 adult patients with R/R DLBCL, PMBCL, and FL3B. 73% of patients responded, including 53% of patients who showed minimal or no detectable lymphoma after the treatment. The media duration of response is 20.2 months.
Cytokine release syndrome (CRS) of any grade occurred in 39% of patients. This was the second CAR T therapy approved in Europe; previously, Abecma received approval for multiple myeloma.
Feb 15, 2022 Pfizer's and OPKO's Ngenla approved by European Commission for pediatric growth hormone deficiency.
Pfizer and OPKO's Ngenla (somatrogon) is approved by the European Commission for pediatric growth hormone deficiency. Ngenla is indicated as a once-weekly injection for pediatrics of age three years and older.
Growth hormone deficiency is a rare disease, impacting 4,000 to 10,000 children worldwide. The approval is based on the open-label Phase 3 active trial, which included 224 prepubertal, treatment-naïve children. The study compared Ngenla once-weekly injection versus Genotropin (somatropin) once-daily. The study met the primary endpoint of non-inferiority versus Genotropin.
Jan 28, 2022
European Commission approved Pfizer's Lorviqua for ALK-positive NSCLC.
Pfizer announced that the European Commission approved Lorviqua (lorlatinib) as a monotherapy for treating patients with ALK-positive non-small-cell lung carcinoma, previously not treated with ALK-inhibitor.
The approval is based on the Phase 3 CROWN trial, in which Lorviqua was compared with Xalkori (crizotinib). The risk of disease progression or death (primary endpoint) was reduced by 72% versus Xalkori. The objective response rate was 76% in the Lorviqua arm versus 58% in the Xalkori arm.
Lorlatinib is approved in the US under the brand name Lorbrena.
Jan 27, 2022
Merck's Keytruda is approved as adjuvant therapy in renal carcinoma patients after surgery.
Merck announced that it received approval from European Commission for Keytruda in patients will renal cell carcinoma as monotherapy following surgery.
The approval is based on Phase 3 KEYNOTE-564 trial, in which 994 patients were enrolled. Keytruda showed significant improvements in disease-free survival, reduced the risk of disease progression or death by 32% compared to placebo after a median follow-up of 23.9 months.
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