Regulatory milestones approvals, filings & regulatory actions · 12 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
Filedacute myeloid leukemia with FUS-ERG fusion2 milestones
Filed
US (FDA)
RYBREVANT
acute myeloid leukemia with FUS-ERG fusion
2024-06-17
“Johnson & Johnson also announced thesubmissionof a Biologics License Application to the U.S. FDA for a fixed combination of amivantamab” jnj.com ↗
“In November 2023, Johnson & Johnsonsubmitteda supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT®” jnj.com ↗
Filed
EU (EMA)
RYBREVANT
acute myeloid leukemia with FUS-ERG fusion
2024-05-31
“submission of an application for the extension of the RYBREVANT®marketing authorization (line extension) to the European Medicines Agency (EMA)” jnj.com ↗
Filedhead and neck squamous cell carcinoma1 milestone
Filed
US (FDA)
RYBREVANT FASPRO
head and neck squamous cell carcinoma
2026-05-31
“Application (sBLA) seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA)” jnj.com ↗
Filednon-small cell lung carcinoma5 milestones
Rejected (CRL)
US (FDA)
RYBREVANT
non-small cell lung carcinoma
2024-12-16
“FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of amivantamab” jnj.com ↗
Filed
EU (EMA)
RYBREVANT®
non-small cell lung carcinoma
2024-05-31
“In October 2023, a type II extension of indication application was submitted to the European Medicines Agency (EMA) seeking approval of RYBREVANT® for this indication.” jnj.com ↗
“announced the submission of an application for the extension of the RYBREVANT® marketing authorization (line extension) to the European Medicines Agency (EMA)” jnj.com ↗
“A type II extension of indication application was also submitted to the EMA seeking approval of RYBREVANT® for this indication.” jnj.com ↗
Filed
EU (EMA)
RYBREVANT
non-small cell lung carcinoma
2024-02-08
“today announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼ (amivantamab)” jnj.com ↗
Filed
EU (EMA)
RYBREVANT
non-small cell lung carcinoma
2023-11-23
“today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with...” jnj.com ↗
“application to the European Medicines Agency seeking approval of subcutaneous therapy of RYBREVANT®▼ (amivantamab) for the treatment of patients with EGFR-mutated non-small...” jnj.com ↗
“In October 2023, a type II extension of indication application was submitted to the European Medicines Agency (EMA) seeking approval of RYBREVANT® for this indication.” jnj.com ↗
“today announced the submission of a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼(amivantamab)” jnj.com ↗
“A submission for the extension of the RYBREVANT®marketing authorization (line extension) was alsosubmittedto the EMA seeking approval for this indication.” jnj.com ↗
“In May 2024, Janssen announced the submission of a marketing authorization application to the EMA for the SC formulation of RYBREVANT® (amivantamab)” halozyme.com ↗
“Johnson & Johnson submits application to the European Medicines Agency seeking approval of subcutaneous formulation of RYBREVANT®▼ (amivantamab)” jnj.com ↗
“Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT®▼ (amivantamab)” jnj.com ↗
“A type II extension of indication application was also submitted to the EMA seeking the approval of RYBREVANT® for this indication.” jnj.com ↗
“were submitted to the European Medicines Agency (EMA) seeking approval of LAZCLUZE™ in combination with RYBREVANT®” jnj.com ↗
Filed
US (FDA)
RYBREVANT®
non-small cell lung carcinoma
2023-08-25
“submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking the expanded approval of RYBREVANT®” jnj.com ↗
“In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT® in combination with LAZCLUZE™” jnj.com ↗
“In November 2023, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT®” jnj.com ↗
“In November 2023, Johnson & Johnson submitted an sBLA to the U.S. FDA for RYBREVANT® in combination with chemotherapy” jnj.com ↗
“In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT®” jnj.com ↗
“The sBLA submission for RYBREVANT® is also intended to satisfy the regulatory requirements” jnj.com ↗
Filedtumor suppressor gene on chromosome 113 milestones
Filed
EU (EMA)
RYBREVANT
tumor suppressor gene on chromosome 11
2023-10-06
“today announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼(amivantamab)” jnj.com ↗
“Janssen Submits Application to the European Medicines Agency for RYBREVANT®▼ (amivantamab) in Combination with Chemotherapy” jnj.com ↗
“Janssen Submits Application to the European Medicines Agency for RYBREVANT (amivantamab) in Combination with Chemotherapy” jnj.com ↗
Filed
EU (EMA)
—
tumor suppressor gene on chromosome 11
2020-12-28
“Johnson & Johnson announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of amivantamab” jnj.com ↗
Filed
US (FDA)
—
tumor suppressor gene on chromosome 11
2020-12-03
“announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab” jnj.com ↗
Johnson & Johnson (NYSE:JNJ) today announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy.
Johnson & Johnson today announced that the European Commission (EC) has approved an extension of the RYBREVANT®▼ (amivantamab) marketing authorisation to include additional subcutaneous (SC) dosing regimens.
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANTFASPRO™ (amivantamab and hyaluronidase-lpuj).
The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer.
Johnson & Johnson (NYSE:JNJ) today announced promising new results from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous (SC) amivantamab monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and platinum-based chemotherapy.
At a median follow-up of 37.8 months, RYBREVANT®plus LAZCLUZE®showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92, P=0.005).
European Commission approves subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Head-to-head comparison data versus osimertinib showed RYBREVANT®(amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The chemotherapy-free combination regimen met the final pre-specified secondary endpoint of OS and demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib.
This approval by the European Commission offers the potential to broaden first-line treatment options and provide a new standard of care for eligible patients.
European Commission approves RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT®(amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT®(amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC) who have not previously received anti-epidermal growth factor receptor (EGFR) therapy.
This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV RYBREVANT®, where historic data has observed an all-grades incidence rate of 67.4 percent.
This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV RYBREVANT, where historic data has observed an all-grades incidence rate of 67.4 percent.
With this milestone, RYBREVANT®plus LAZCLUZE™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.
Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT®(amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC).
SC amivantamab was associated with significantly lower rates of infusion-related reactions (IRRs) and shorter treatment time compared with the IV formulation.
Results from the new analysis show the RYBREVANT®combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations.
Study results showed non-inferior efficacy and pharmacokinetics for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT®(amivantamab-vmjw).
Study results showed non-inferior efficacy and pharmacokinetics for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT ® (amivantamab-vmjw).
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼ (amivantamab), in combination with lazertinib
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT®▼(amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼(amivantamab)
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).
As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for RYBREVANT in this expanded patient population.
Results also showed that the two RYBREVANT®regimens significantly improved objective response rate (ORR), intracranial progression-free survival (PFS), and duration of response (DOR) compared to chemotherapy alone in these patients.
With the combination of RYBREVANT and lazertinib in the MARIPOSA study, progression-free survival was significantly improved in patients with previously untreated EGFR-mutated NSCLC compared to osimertinib.
Results also showed treatment with RYBREVANT®plus chemotherapy significantly improved objective response rate (ORR) and progression-free survival (PFS) after first subsequent therapy (PFS2).
Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions
Today’s submission to the EMA highlights our deep commitment to change the trajectory of lung cancer, through earlier intervention with targeted treatment options for eligible patients.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non -small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT®plus lazertinib compared to osimertinib.
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT® plus lazertinib compared to osimertinib.
The combination of RYBREVANT®and lazertinib with chemotherapy yielded an objective response rate of 50 percent, with 11 out of 20 patients remaining on treatment.
Data presented at WCLC showed combining RYBREVANT ®, lazertinib and chemotherapy may address the diverse resistance that emerges after disease progression on osimertinib
Results showed the PAPILLON Phase 3 study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT®plus chemotherapy versus chemotherapy alone.
Results showed the PAPILLON Phase 3 study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS)
After a median follow-up of nearly three years (33.6 months), the median duration of response (DOR), median progression-free survival (PFS) and overall survival (OS) were not yet reached.
After a median follow-up of 19.2 months, the median OS with RYBREVANT®treatment was 23 months (95 percent Confidence Interval [CI], 18.5–29.5) with a two-year OS rate of 47 percent.
After a median follow-up of 7.1 months, the combination of RYBREVANT®and lazertinib with carboplatin and pemetrexed yielded an overall response rate (ORR) of 50 percent (95 percent confidence interval [CI];27-73), with 15 out of 20 patients remaining on treatment.
After a median follow-up of 7.1 months, the combination of RYBREVANT® and lazertinib with carboplatin and pemetrexed yielded an overall response rate (ORR) of 50 percent (95 percent confidence interval [CI];27-73), with 15 out of 20 patients remaining on treatment.
Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy
The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting theextracellular (outer) and catalytic (internal) domains ofEGFR, even in patients with documented resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs).
While previously reported results have demonstrated durable responses with RYBREVANT®in combination with lazertinib in chemotherapy-naïve patients previously treated with osimertinib, these new data suggest that intervening chemotherapy does not impact activity with the combination.
The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting the extracellular (outer) and catalytic (internal) domains of EGFR, even in patients with documented resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs).
While previously reported results have demonstrated durable responses with RYBREVANT® in combination with lazertinib in chemotherapy-naïve patients previously treated with osimertinib, these new data suggest that intervening chemotherapy does not impact activity with the combination.
The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANTTM1050 mg [<80 kg] / 1400 mg [≥80 kg]).
The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANTTM 1050 mg [<80 kg] / 1400 mg [≥80 kg]).
RYBREVANTTMis the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.
RYBREVANTTM (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
The key findings showed robust activity and durable responses with a tolerable and manageable safety profile (Abstract #3031) in patients with NSCLC and EGFR exon 20 insertion mutations, a mutation for which no targeted therapies are currently approved.
The application marks the first-ever regulatory submission in the EU for a treatment for patients with NSCLC that specifically targets EGFR exon 20 insertion mutations.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations
“Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).” NCT04606381 ↗
Known as
Ami-HC-CF
“Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).” NCT04606381 ↗
Known as
Ami-LC
“Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC)...” NCT04606381 ↗
Known as
amivantamab-vmjw
“The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal-epithelial...” PMID 37022784 ↗Sep 2023
Known as
CNTO-4424
ChEMBL registry synonym — accepted as the source's own labelCHEMBL4297774 ↗
Known as
JNJ-611
ChEMBL registry synonym — accepted as the source's own labelCHEMBL4297774 ↗
Known as
JNJ-61186372
“A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic...” NCT07042295 ↗
Known as
JNJ-6372
ChEMBL registry synonym — accepted as the source's own labelCHEMBL4297774 ↗
Known as
RYBREVANT
“This part of the CHRYSALIS study (called cohort D) investigated the bispecific antibody amivantamab (brand name RYBREVANT®) in patients with non-small-cell lung cancer (NSCLC)...” PMID 37589131 ↗Aug 2023
“Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity” PMID 34339292 ↗Aug 2021
Route
Intravenous
“1050 mg administered IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in...” NCT03767075 ↗
Target
EGFR
“Amivantamab, an epidermal growth factor receptor (EGFR)-c-Met bispecific antibody, targets activating/resistance EGFR mutations and MET mutations/amplifications.” PMID 35963523 ↗Aug 2022
Target
MET
“Amivantamab, an epidermal growth factor receptor (EGFR)-c-Met bispecific antibody, targets activating/resistance EGFR mutations and MET mutations/amplifications.” PMID 35963523 ↗Aug 2022