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J&J's (JNJ) Amivantamab Gets FDA Nod for Rare Lung Cancer
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J&J (JNJ - Free Report) announced that the FDA has granted accelerated approval to amivantamab for treating adult patients with EGFR-mutated non-small cell lung cancer (NSCLC). The drug will be marketed by the trade name of Rybrevant for treating patients whose NSCLC disease has progressed on or after platinum-based chemotherapy and targets EGFR exon 20 insertion mutations, as detected by an FDA-approved test. With the FDA nod, Rybrevant becomes the first fully-human, bispecific antibody approved for the treatment of patients this serious and rare type of lung cancer.
EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation and no medicines are approved yet for these mutations.
Continued approval for the indications will be dependent on verification and description of clinical benefit in the confirmatory studies. The FDA also simultaneously approved California-based precision oncology company, Guardant Health’s (GH - Free Report) Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with Rybrevant.
The biologics license application (BLA) submission for amivantamab was based on data from the monotherapy arm of the phase I CHRYSALIS study, which evaluated amivantamab as a monotherapy as well as in combination with third-generation tyrosine-kinase inhibitor (TKI) lazertinib in advanced NSCLC.
This year so far, J&J’s shares have risen 8.6% compared with an increase of 7.4% for the industry.
Oncology is an important therapeutic area for J&J. Key cancer drugs in J&J’s portfolio are Imbruvica and Darzalex. Both drugs have been key drivers of J&J’s sales growth in the past three years,driven by consistent uptake and new indications added to their approved labels. J&J markets Imbruvica in partnership with AbbVie (ABBV - Free Report) .
A key candidate in its oncology pipeline is its CAR-T therapy, ciltacabtagene autoleucel, which is under review in the United States and EU for the treatment of patients with relapsed/refractory multiple myeloma.
In a separate press release, J&J announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending expanded use of Darzalex subcutaneous (SC) formulation for two new indications in Europe. The first indication is for expanded use of Darzalex SC in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly diagnosed systemic light chain (AL) amyloidosis, a rare blood cell disorder. The second indication is for combination use with pomalidomide and dexamethasone (D-Pd) to treat adult patients with pre-treated multiple myeloma (MM)
A better-ranked stock in the healthcare sector is BioNTech (BNTX - Free Report) ,which has a Zacks Rank of 1.
BioNTech’s earnings estimates have risen from $10.91 per share to $29.44 per share for 2021 and from $7.34 per share to $21.34 per share for 2022 in the past 60 days. The stock is up 140% this year so far.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
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J&J's (JNJ) Amivantamab Gets FDA Nod for Rare Lung Cancer
J&J (JNJ - Free Report) announced that the FDA has granted accelerated approval to amivantamab for treating adult patients with EGFR-mutated non-small cell lung cancer (NSCLC). The drug will be marketed by the trade name of Rybrevant for treating patients whose NSCLC disease has progressed on or after platinum-based chemotherapy and targets EGFR exon 20 insertion mutations, as detected by an FDA-approved test. With the FDA nod, Rybrevant becomes the first fully-human, bispecific antibody approved for the treatment of patients this serious and rare type of lung cancer.
EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation and no medicines are approved yet for these mutations.
Continued approval for the indications will be dependent on verification and description of clinical benefit in the confirmatory studies. The FDA also simultaneously approved California-based precision oncology company, Guardant Health’s (GH - Free Report) Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with Rybrevant.
The biologics license application (BLA) submission for amivantamab was based on data from the monotherapy arm of the phase I CHRYSALIS study, which evaluated amivantamab as a monotherapy as well as in combination with third-generation tyrosine-kinase inhibitor (TKI) lazertinib in advanced NSCLC.
This year so far, J&J’s shares have risen 8.6% compared with an increase of 7.4% for the industry.
Oncology is an important therapeutic area for J&J. Key cancer drugs in J&J’s portfolio are Imbruvica and Darzalex. Both drugs have been key drivers of J&J’s sales growth in the past three years,driven by consistent uptake and new indications added to their approved labels. J&J markets Imbruvica in partnership with AbbVie (ABBV - Free Report) .
A key candidate in its oncology pipeline is its CAR-T therapy, ciltacabtagene autoleucel, which is under review in the United States and EU for the treatment of patients with relapsed/refractory multiple myeloma.
In a separate press release, J&J announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending expanded use of Darzalex subcutaneous (SC) formulation for two new indications in Europe. The first indication is for expanded use of Darzalex SC in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly diagnosed systemic light chain (AL) amyloidosis, a rare blood cell disorder. The second indication is for combination use with pomalidomide and dexamethasone (D-Pd) to treat adult patients with pre-treated multiple myeloma (MM)
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked stock in the healthcare sector is BioNTech (BNTX - Free Report) ,which has a Zacks Rank of 1.
BioNTech’s earnings estimates have risen from $10.91 per share to $29.44 per share for 2021 and from $7.34 per share to $21.34 per share for 2022 in the past 60 days. The stock is up 140% this year so far.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>