Drug approvals in Europe| EMA drug approvals in 2022 |European Commission News| iPharmaCenter
- ipharmaservices
- Jan 26, 2023
- 8 min read
Updated: Mar 6, 2023
December 21, 2022
EMA approved Lynparza, Zytiga, and prednisone or prednisolone combination for metastatic castration-resistant prostate cancer.
Merck and AstraZeneca announced that the combination of Lynparza (olaparib), Zytiga (abiraterone), and prednisone or prednisolone was approved for treating metastatic castration-resistant prostate cancer.
The approval was based on the Phase 3 PROpel trial, demonstrating the efficacy of the Lynparza combination versus placebo. The combination was evaluated in patients with mCRPC undergoing first-line treatment following the failure of primary androgen deprivation therapy. Patients were randomized in a 1:1 ratio; the primary endpoint was progression-free survival versus placebo. The rPFS was 24.8 months in patients on the Lynparza combination versus 16.6 months in patients on placebo. A trend in overall survival favoring the Lynparza combination was demonstrated versus placebo.
The safety profile was consistent with the previously reported profile of individual drugs.
In Europe, prostate cancer is the most common cancer in men. Nearly 473,000 cases were reported in 2020, causing 108,000 deaths.
In the US, FDA has extended the review time by three months, and it mentioned that it needs more time for complete evaluation.
November 23, 2022
Skyrizi is approved for Crohn's Disease in Europe.
AbbVie announced that Skyrizi (risankizumab) was approved by European Commission for treating adults with moderate to severe Crohn's disease. It is indicated for patients with inadequate response or intolerant to conventional or biological therapy.
The approval was based on ADVANCE induction, MOTIVATE induction and FORTIFY maintenance study.
In the ADVANCE and MOTIVATE induction trial, 43% and 35% of patients achieved clinical remission at week 12 versus 22% and 19% in patients on placebo, respectively. At week 12, 40% and 29% of patients showed endoscopic response versus 12% and 11% of patients on placebo.
In the FORTIFY maintenance trial, patients were administered with Skyrizi 360 mg SC. At week 52, 52% of patients had clinical remission versus 40% on placebo. At week 52, 39% of patients showed endoscopic remission versus 13% on placebo.
Skyrizi was previously approved for psoriasis and psoriatic arthritis.
November 17, 2022
Enjaymo was approved in Europe for hemolytic anemia in adults with cold agglutinin disease.
Enjaymo (sutimlimab) was approved for treating hemolytic anemia in adults with cold agglutinin disease, a rare chronic autoimmune hemolytic anemia.
The approval was based on two Phase 3 clinical trials, CADENZA and CARDINAL. CADENZA is a Phase 3 placebo-controlled trial without a recent history of blood transfusion. CARDINAL is a Phase 3 placebo-controlled trial with a recent history of blood transfusion.
In Part-A of the CADENZA trial, a fixed dose of Enjaymo was administered on Day 0 and Day 7, followed by administration every week until Week 26. The primary endpoint was proportion of patients who did not receive a blood transfusion from Week 5 through Week 26, Hgb level >= 12g/dL at the treatment assessment endpoint, or Hgb increased >= 2 g/dL from baseline. Enjaymo met the primary endpoint and all secondary endpoints. In the Part-B study, long-term safety and durability of response were assessed.
In Part-A of the CARDINAL trial, a fixed dose of Enjaymo was administered on Day 0 and Day 7, followed by administration every week until Week 26. The co-primary endpoints were Hb≥12 g/dL or an increase of at least two g/dL and no blood transfusion or prohibited medications from Weeks 5 through 26.
Enjaymo was approved in the US in February 2022 and in Japan in June 2022.
September 21, 2022
AstraZeneca's Tezspire received EMA approval for severe asthma.
AstraZeneca announced that the European Commission approved Tezspire (tezepelumab) for patients (12 years and older) with severe asthma. It is indicated for patients with inadequate response to corticosteroids plus standard of care.
The approval was based on the NAVIGATOR Phase III trial, aimed at assessing the efficacy of Tezspire versus placebo when added to standard therapy in adults and adolescents (12 years and older). The primary efficacy endpoint was annualized asthma exacerbation rate (AAER) during the 52-week treatment period.
The annualized asthma exacerbation rate was 0.93 in the Tezspire arm compared to 2.10 in patients on placebo. The rate of exacerbation requiring hospitalization was 0.03 in patients on Tezspire versus 0.19 in patients on placebo.
Tezspire is administered every four weeks. Some of the adverse events of Tezspire are severe allergic reactions, including rashes or eye allergy.
August 24, 2022
Janssen's Tecvayli received EMA approval for multiple myeloma.
Janssen announced that the European Commission provided conditional marketing authorization for Tecvayli (teclistamab) as a monotherapy for patients with relapsed or refractory multiple myeloma. The patients must be treated with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody before administrating Tecvayli.
The approval was based on the Phase 1/2 MajesTEC-1 study, which enrolled 165 patients with relapsed or refractory multiple myeloma. The patients were administered the subcutaneous injection at a dose of 1.5 mg/kg following step-up doses. The overall response rate was 63% after a median follow-up of 14.1 months. 58.8% of patients treated with Tecvayli achieved a very good partial response (VGPR) or better, and 39.4% achieved a complete response rate. No minimal residual disease was observed in 44 patients. The median progression-free survival was 11.3 months, and the median overall survival was 18.3 months.
Multiple myeloma is a blood cancer that often relapses and is an indication with a high unmet need for subsequent therapies. T-cell–redirecting bispecific antibody acts by targeting CD3 expressed on the surface of T-cells and B-cell maturation antigen expression on myeloma cells.
June 28, 2022
European Commission approved Yescarta for treating patients with relapsed or refractory follicular lymphoma.
Gilead announced that the European Commission approved Yescarta (axicabtagene ciloleucel) for follicular lymphoma. It is indicated for adult patients with relapsed or refractory lymphoma (FL) who were previously treated with three or more lines of systemic therapy.
Also read: 2022 FDA Approvals
The approval was based on Phase 2 ZUMA-5 study; in patients who were administered Yescarta after previously treated with three or more lines of treatment, the overall response rate was 91%, and the complete response rate was 77%.
Yescarta has the orphan designation for follicular lymphoma.
May 26, 2022
European Commission gave conditional approval to Janssen's Carvykti for relapsed or refractory multiple myeloma.
European Commission granted conditional approval for Carvykti (ciltacabtagene autoleucel) to treat adult patients with relapsed or refractory multiple myeloma. It is indicated for patients who were previously treated with three other therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The conditional approval was based on the CARTITUDE-1 study, which included patients who had received a median of prior six therapies (3-18 was the range). After a median duration of 18 months, 98% of patients with RRMM responded to the treatment. 80% of patients achieved stringent complete response.
The drug's long-term safety profile is under evaluation in the ongoing CARTITUDE-1 study.
May 23, 2022
EMA approved AstraZeneca's Vaxzevria as a booster shot against COVID19
AstraZeneca has announced that the European Medicine Agency (EMA) approved Vaxzevria as a booster short against COVID19. Vaxzevria can be administered to the population who were previously administered either Vaxzevria or mRNA COVID vaccines.
Vaxzevria is approved in the UK, Asian, and African countries as a booster dose against COVID19.
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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