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Mirati's (MRTX) Krazati Gets Breakthrough Therapy Tag for CRC
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Mirati Therapeutics, Inc. announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its KRAS inhibitor Krazati (adagrasib) for treating a new cancer indication.
The FDA has granted the BTD to Krazati in combination with Erbitux (cetuximab) for treating patients with KRASG12C-mutated, advanced colorectal cancer (CRC), whose disease has progressed following prior treatments with chemotherapy and anti-VEGF therapy.
A BTD is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The above BTD was based on data from the phase Ib cohort of the KRYSTAL-1 study, which evaluated Krazati as monotherapy or in combination with cetuximab in patients with KRASG12C-mutated metastatic CRC.
Shares of Mirati have plunged 71.8% year to date compared with the industry’s decline of 20.5%.
Image Source: Zacks Investment Research
Earlier this month, the FDA granted accelerated approval to Krazati for previously-treated KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Krazati is the first approved drug in Mirati’s portfolio.
Tumors characterized by KRAS mutations are extremely difficult to directly inhibit and are commonly associated with poor prognosis and resistance to therapy.
We note that Krazati is likely to face competition from Amgen’s (AMGN - Free Report) KRAS G12C inhibitor, Lumakras/ Lumykras, which was approved for second-line NSCLC in the United States in 2021 and Europe in January 2022. It has now been launched in more than 45 countries.
Amgen’s Lumakras/ Lumykras is off to an excellent start as its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly.
In the first nine months of 2022, Lumakras/ Lumykras generated sales of $214 million for AMGN.
Mirati is also evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include the combination of adagrasib with Merck’s (MRK - Free Report) blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab) in NSCLC.
Merck’s biggest revenue generator Keytruda is approved for treating several types of cancer indications. MRK continues to study Keytruda for addressing more cancer indications.
Successful development of adagrasib for additional indications will boost Mirati’s growth prospects in the days ahead.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 7.7% for 2022 and 7.4% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
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Mirati's (MRTX) Krazati Gets Breakthrough Therapy Tag for CRC
Mirati Therapeutics, Inc. announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its KRAS inhibitor Krazati (adagrasib) for treating a new cancer indication.
The FDA has granted the BTD to Krazati in combination with Erbitux (cetuximab) for treating patients with KRASG12C-mutated, advanced colorectal cancer (CRC), whose disease has progressed following prior treatments with chemotherapy and anti-VEGF therapy.
A BTD is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The above BTD was based on data from the phase Ib cohort of the KRYSTAL-1 study, which evaluated Krazati as monotherapy or in combination with cetuximab in patients with KRASG12C-mutated metastatic CRC.
Shares of Mirati have plunged 71.8% year to date compared with the industry’s decline of 20.5%.
Image Source: Zacks Investment Research
Earlier this month, the FDA granted accelerated approval to Krazati for previously-treated KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Krazati is the first approved drug in Mirati’s portfolio.
Tumors characterized by KRAS mutations are extremely difficult to directly inhibit and are commonly associated with poor prognosis and resistance to therapy.
We note that Krazati is likely to face competition from Amgen’s (AMGN - Free Report) KRAS G12C inhibitor, Lumakras/ Lumykras, which was approved for second-line NSCLC in the United States in 2021 and Europe in January 2022. It has now been launched in more than 45 countries.
Amgen’s Lumakras/ Lumykras is off to an excellent start as its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly.
In the first nine months of 2022, Lumakras/ Lumykras generated sales of $214 million for AMGN.
Mirati is also evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include the combination of adagrasib with Merck’s (MRK - Free Report) blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab) in NSCLC.
Merck’s biggest revenue generator Keytruda is approved for treating several types of cancer indications. MRK continues to study Keytruda for addressing more cancer indications.
Successful development of adagrasib for additional indications will boost Mirati’s growth prospects in the days ahead.
Zacks Rank & Stock to Consider
Mirati currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is ASLAN Pharmaceuticals Limited (ASLN - Free Report) , carrying a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 7.7% for 2022 and 7.4% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.